Selecting high-quality OEM surgical disposable nitrile rubber medical gloves is critical for ensuring safety and efficiency in surgical environments. These gloves provide essential protection against punctures, bacteria, and chemicals, meeting rigorous standards like ISO13485 and CE certifications.
The nitrile gloves market is projected to grow at 5.39% annually from 2025 to 2033, driven by rising healthcare demands, strict hygiene protocols, and an aging population requiring more medical procedures.
This growth underscores the increasing reliance on durable and reliable medical gloves for surgical applications.
Key Takeaways
- Picking good OEM makers for surgical gloves is important. It helps keep healthcare safe and efficient.
- Check if the makers have certifications like ISO13485 and FDA approval. These show the gloves are safe and high-quality.
- Look at glove features like strength, puncture resistance, and comfort. Choose gloves that work best for surgeries.
Manufacturer 1: The Safety Zone
Background and Overview
The Safety Zone, a prominent player in the personal protective equipment (PPE) industry, has been delivering high-quality products for over four decades. Based in the United States, the company specializes in manufacturing gloves, safety apparel, and other protective solutions. Its commitment to innovation and quality has earned it a strong reputation among healthcare providers and industrial users. The Safety Zone focuses on creating products that meet the highest safety standards while ensuring user comfort.
Certifications and Standards
The Safety Zone adheres to stringent industry standards to ensure the reliability of its products. Its disposable nitrile gloves comply with ISO13485 and FDA regulations, making them suitable for medical and surgical applications. The company also meets ASTM standards for puncture resistance and chemical protection. These certifications demonstrate its dedication to producing gloves that prioritize safety and performance.
Product Range
The Safety Zone offers an extensive range of disposable nitrile gloves tailored to various industries, including healthcare, food service, and manufacturing. Its product line includes powder-free and latex-free gloves, ensuring compatibility with sensitive skin. The gloves are available in multiple sizes and thicknesses, catering to diverse user needs. The company also provides OEM Surgical Disposable Nitrile rubber medical gloves, designed specifically for surgical environments.
Unique Features for Surgical Applications
The Safety Zone’s surgical nitrile gloves stand out for their superior durability and tactile sensitivity. These gloves provide excellent barrier protection against pathogens and chemicals, ensuring safety during critical procedures. Their textured fingertips enhance grip, even in wet conditions, while the ambidextrous design simplifies usage. The gloves are also designed to minimize hand fatigue, making them ideal for extended surgical procedures.
Manufacturer 2: HOSPECO
Background and Overview
HOSPECO, short for the Hospital Specialty Company, has been a trusted name in the healthcare and hygiene industry for decades. Headquartered in Cleveland, Ohio, the company specializes in manufacturing disposable gloves, feminine hygiene products, and restroom supplies. HOSPECO’s dedication to quality and innovation has made it a preferred choice for healthcare providers, industrial users, and OEM partners. Its focus on safety and performance ensures that its products meet the demands of critical environments, including surgical applications.
Certifications and Standards
HOSPECO’s gloves are rigorously tested to meet stringent safety and quality standards. Key certifications include:
- Compliance with ASTM D6978 standards for chemical protection.
- Design of KODA® Powder Free Nitrile Exam Gloves to safeguard against hazardous substances like fentanyl and chemotherapy agents.
- Adherence to high-quality safety benchmarks through extensive testing.
These certifications highlight HOSPECO’s commitment to producing reliable and protective gloves for medical and surgical use.
Product Range
HOSPECO offers a diverse selection of disposable gloves tailored to various industries. Its product line includes nitrile, latex, and vinyl gloves, with options for powder-free and textured finishes. The KODA® series, in particular, stands out for its advanced chemical resistance and durability. The company also provides OEM Surgical Disposable Nitrile rubber medical gloves, designed to meet the specific needs of surgical environments. These gloves are available in multiple sizes and thicknesses, ensuring a perfect fit for every user.
Unique Features for Surgical Applications
HOSPECO’s surgical nitrile gloves are engineered for precision and safety. Their superior chemical resistance protects against exposure to hazardous substances, making them ideal for high-risk procedures. The gloves feature a textured surface for enhanced grip and tactile sensitivity, ensuring accuracy during delicate tasks. Additionally, their ergonomic design reduces hand fatigue, allowing healthcare professionals to perform extended procedures comfortably.
HOSPECO’s commitment to innovation and safety makes it a reliable partner for surgical glove solutions.
Manufacturer 3: CILIANG
Background and Overview
CILIANG is a global innovation leader that has been at the forefront of manufacturing high-quality products for more than a century. Headquartered in Ningbo, Zhejiang, China, the company operates across multiple industries including healthcare, consumer products, and industrial solutions. Its healthcare division is well known for producing reliable and advanced medical supplies, including surgical gloves. CILIANG’s commitment to research and development ensures that its products meet the evolving needs of healthcare professionals around the world.
Certifications and Standards
CILIANG adheres to strict international standards to guarantee the safety and performance of its products. Its surgical nitrile gloves comply with ISO13485, ensuring quality management of medical devices. These gloves also meet ASTM standards for puncture resistance and chemical protection. In addition, CILIANG’s products are FDA-approved for use in critical surgical environments. These certifications reflect the company’s commitment to providing reliable solutions for healthcare providers.
Product Range
CILIANG offers a wide range of disposable nitrile gloves for a variety of applications. Its product line includes powder-free and latex-free options to meet the needs of users with sensitive skin. The gloves are available in a variety of sizes and thicknesses to ensure a comfortable fit for all users. Among its products, CILIANG offers OEM surgical disposable nitrile medical gloves tailored for surgical procedures. These gloves are designed to provide superior performance in demanding medical environments.
Unique Features for Surgical Applications
CILIANG’s surgical nitrile gloves are engineered for precision and durability. They provide excellent barrier protection against pathogens and hazardous chemicals, ensuring safety during critical surgeries. The gloves feature a textured surface for enhanced grip even in wet conditions and provide superior tactile sensitivity for delicate tasks. Its ergonomic design reduces hand fatigue, making it ideal for long-term use in surgical environments. These features make CILIANG a reliable choice for healthcare professionals seeking dependable surgical gloves.
Manufacturer 4: Ansell Ltd
Background and Overview
Ansell Ltd, a global leader in protective solutions, has been serving the healthcare and industrial sectors for over 125 years. Headquartered in Melbourne, Australia, the company operates in more than 55 countries, offering innovative products that prioritize safety and performance. Ansell’s expertise in glove manufacturing has positioned it as a trusted partner for healthcare providers worldwide. Its commitment to sustainability and innovation ensures that its products meet the evolving demands of modern surgical environments.
Certifications and Standards
Ansell’s gloves meet rigorous industry certifications, ensuring their suitability for surgical applications. These include:
- CE certification for compliance with European safety standards.
- FDA approval for medical-grade products.
- Certificates of Inspection (CoI), Conformance (CoP), and Analysis (CoA).
These certifications highlight Ansell’s dedication to producing high-quality gloves that meet global safety and performance benchmarks.
Product Range
Ansell offers a diverse range of gloves tailored to various industries, including healthcare, food processing, and manufacturing. The company produces approximately 10 billion pairs annually, supported by 15 factories worldwide. A new facility in Tamil Nadu, India, contributes an additional 500 million pairs per year.
| Manufacturer | Production Capacity | Customization Options |
|---|---|---|
| Ansell | ~10B pairs/year | Colors, branding, specialized coatings |
Ansell’s product line includes OEM Surgical Disposable Nitrile rubber medical gloves, designed to meet the specific needs of surgical environments. These gloves are available in various sizes, colors, and coatings, ensuring a perfect fit and enhanced functionality.
Unique Features for Surgical Applications
Ansell’s surgical nitrile gloves are engineered for precision and durability. They provide exceptional barrier protection against pathogens and chemicals, ensuring safety during critical procedures. The gloves feature advanced coatings that enhance grip and tactile sensitivity, even in wet conditions. Their ergonomic design minimizes hand fatigue, making them ideal for extended surgical use. Ansell’s focus on innovation and quality makes it a reliable choice for healthcare professionals seeking dependable surgical gloves.
Manufacturer 5: Kossan
Background and Overview
Kossan Rubber Industries, headquartered in Malaysia, is a globally recognized leader in the production of high-quality medical gloves. Established in 1979, the company has grown into one of the largest manufacturers of nitrile gloves, serving healthcare providers worldwide. Kossan’s commitment to innovation and sustainability has positioned it as a trusted partner in the medical industry. The company focuses on delivering products that meet the highest safety and performance standards, ensuring reliability in critical surgical environments.
Certifications and Standards
Kossan’s products comply with rigorous international standards, ensuring their suitability for surgical applications. The company holds several certifications, including:
- ISO (International Organization for Standardization)
- OHSAS (Occupational Health and Safety Assessment Series)
- IEC (International Electrotechnical Commission)
- TS (Technical Specifications)
These certifications highlight Kossan’s dedication to quality, safety, and environmental responsibility.
Product Range
Kossan offers an extensive range of medical gloves, including OEM Surgical Disposable Nitrile rubber medical gloves, tailored to meet diverse surgical needs. The company’s strong manufacturing capabilities and focus on innovation enable it to produce a wide variety of gloves.
| Evidence Description | Source |
|---|---|
| Kossan is recognized for its strong manufacturing capabilities and diverse product range in the medical gloves market. | DataIntelo |
| The company focuses on expanding production capacities and enhancing distribution networks to meet growing market demand. | DataIntelo |
| Kossan was the second-leading company in the Medical Nitrile Gloves market in 2020, indicating its extensive product range. | Market Research Future |
| The company is well-known for developing a variety of nitrile gloves products, showcasing its diverse offerings. | Market Research Future |
Unique Features for Surgical Applications
Kossan’s surgical nitrile gloves are designed to provide exceptional protection and comfort. These gloves offer superior resistance to punctures and chemicals, ensuring safety during high-risk procedures. Their textured surface enhances grip, even in wet conditions, while the ergonomic design minimizes hand fatigue. Kossan’s focus on innovation ensures that its gloves deliver excellent tactile sensitivity, making them ideal for precision tasks in surgical environments.
Kossan’s dedication to quality and innovation makes it a reliable choice for healthcare professionals seeking dependable surgical gloves.
Manufacturer 6: American Nitrile
Background and Overview
American Nitrile, based in the United States, is a leading manufacturer of high-quality nitrile gloves. The company operates a state-of-the-art 530,000-square-foot facility, producing up to 120 million gloves per month. Its focus on domestic production ensures a reliable supply chain and supports sustainable manufacturing practices. American Nitrile caters to both medical and industrial sectors, offering products designed to meet the highest safety and performance standards. By prioritizing innovation and sustainability, the company has established itself as a trusted partner in the healthcare industry.
Certifications and Standards
American Nitrile adheres to stringent industry standards to ensure the safety and reliability of its products. The company’s gloves comply with FDA regulations and meet ASTM standards for puncture resistance and chemical protection. These certifications demonstrate American Nitrile’s commitment to delivering products that meet the rigorous demands of surgical and medical environments.
Product Range
American Nitrile offers a diverse range of nitrile gloves tailored for medical and industrial applications. Its product line includes disposable gloves designed for healthcare providers, industrial workers, and food service professionals. The company’s OEM Surgical Disposable Nitrile rubber medical gloves are specifically engineered for surgical use, providing exceptional durability and protection.
| Manufacturer | Product Details | Technical Parameters | Application Scenarios | Pros | Cons |
|---|---|---|---|---|---|
| American Nitrile | Medical and industrial nitrile gloves made in the USA | 120 million gloves/month, 530,000 sq ft facility | Healthcare, Industrial use | High-quality manufacturing, Sustainable practices | Limited glove type information, Higher costs compared to imports |
| Nephron Nitrile | Premium American-made nitrile gloves | FDA registered, Compliant with ASTM and ISO | Medical applications, General purpose | Competitive pricing, Reliable supply chain | Limited glove size information, Availability issues during high demand |
This comparison highlights American Nitrile’s focus on high-quality manufacturing and sustainability, setting it apart from competitors.
Unique Features for Surgical Applications
American Nitrile’s surgical gloves are designed to provide superior protection and comfort. These gloves offer excellent resistance to punctures and chemicals, ensuring safety during critical procedures. Their ergonomic design reduces hand fatigue, making them suitable for extended use. The gloves also feature a textured surface for enhanced grip, even in wet conditions. By combining durability with precision, American Nitrile delivers products that meet the exacting standards of surgical environments.
Manufacturer 7: Medline
Background and Overview
Medline Industries, LP, is a leading global manufacturer and distributor of healthcare supplies. Headquartered in Northfield, Illinois, Medline has been serving the healthcare industry for over 50 years. The company operates in more than 125 countries, offering a wide range of medical products and solutions. Medline’s focus on innovation and customer-centricity has made it a trusted partner for hospitals, surgical centers, and healthcare providers worldwide. Its extensive product portfolio includes surgical gloves, wound care products, and infection prevention solutions.
Certifications and Standards
Medline ensures its products meet the highest safety and quality standards. The company’s surgical nitrile gloves comply with ISO13485, FDA regulations, and ASTM standards for puncture resistance and chemical protection. These certifications demonstrate Medline’s commitment to delivering reliable and safe products for surgical applications. Additionally, the company’s manufacturing facilities adhere to strict quality control processes, ensuring consistent product performance.
Product Range
Medline offers a comprehensive range of disposable gloves, including nitrile, latex, and vinyl options. Its product line caters to various industries, such as healthcare, food service, and industrial sectors. Among its offerings, Medline provides OEM Surgical Disposable Nitrile rubber medical gloves, specifically designed for surgical environments. These gloves are available in multiple sizes and thicknesses, ensuring a comfortable fit and optimal protection for healthcare professionals.
Unique Features for Surgical Applications
Medline’s surgical nitrile gloves are engineered for precision and durability. They provide excellent barrier protection against pathogens and hazardous chemicals, ensuring safety during critical procedures. The gloves feature a textured surface for enhanced grip and tactile sensitivity, even in wet conditions. Their ergonomic design reduces hand fatigue, making them suitable for extended use. Medline’s focus on quality and innovation ensures its gloves meet the demanding requirements of surgical environments.
Manufacturer 8: Top Glove Corporation Bhd
Background and Overview
Top Glove Corporation Bhd, headquartered in Malaysia, is one of the largest manufacturers of gloves globally. Established in 1991, the company has grown into a dominant player in the nitrile gloves market, holding a significant market share. Its extensive distribution network spans over 195 countries, ensuring a reliable supply of high-quality gloves to healthcare providers worldwide. Top Glove’s commitment to innovation and sustainability has solidified its reputation as a trusted partner in the medical industry.
Certifications and Standards
Top Glove adheres to stringent international standards to ensure the safety and quality of its products. The company holds several certifications that highlight its commitment to excellence:
| Certification | Description |
|---|---|
| ISO 13485 | Medical device quality management (critical for exporting to the EU). |
| Halal Certification | A must for food clients in Muslim-majority markets. |
| FDA 510(k) Clearance | Fast-track approval for U.S. medical sales. |
These certifications demonstrate Top Glove’s dedication to meeting global safety and regulatory requirements, making its products suitable for surgical and medical applications.
Product Range
Top Glove offers a diverse range of gloves tailored to various industries, including healthcare, food service, and industrial sectors. Its product portfolio includes:
- Nitrile gloves
- Latex gloves
- PVC gloves
- PE gloves
- Polychloroprene gloves
- Polyisoprene gloves
The company focuses on producing high-quality nitrile examination gloves, which are widely recognized for their durability and comfort. Its OEM Surgical Disposable Nitrile rubber medical gloves are specifically designed to meet the rigorous demands of surgical environments.
Unique Features for Surgical Applications
Top Glove’s surgical nitrile gloves are engineered to provide exceptional protection and comfort. These gloves offer superior resistance to punctures and chemicals, ensuring safety during high-risk procedures. Their textured surface enhances grip, even in wet conditions, while the ergonomic design minimizes hand fatigue. By combining durability with precision, Top Glove delivers products that meet the exacting standards of surgical environments. Its focus on innovation and quality makes it a reliable choice for healthcare professionals seeking dependable surgical gloves.
Manufacturer 9: Cardinal Health
Background and Overview
Cardinal Health, headquartered in Dublin, Ohio, is a global leader in healthcare services and products. With over 100 years of experience, the company operates in more than 30 countries, serving hospitals, surgical centers, and healthcare providers. Cardinal Health is renowned for its comprehensive portfolio of medical supplies, including surgical gloves, pharmaceuticals, and infection prevention solutions. Its commitment to innovation and quality has established it as a trusted partner in the healthcare industry.
Certifications and Standards
Cardinal Health adheres to rigorous certifications and standards to ensure the safety and reliability of its products. The company has achieved the following certifications:
| Certification/Standard | Description |
|---|---|
| NCQA Certification in Utilization Management | Recognized for quality care and patient services through rigorous audits. |
| Good Manufacturing Practices (cGMP) | Ensures compliance with FDA requirements for quality, consistency, and purity. |
| USP <797> Standards | Meets sterile compounding standards with minimal operational impact. |
| USP General Chapter <825> | Complies with standards for radiopharmaceutical preparation and dispensing. |
These certifications highlight Cardinal Health’s dedication to maintaining high-quality manufacturing processes and patient safety.
Product Range
Cardinal Health offers a diverse range of disposable gloves, including nitrile, latex, and vinyl options. Its OEM Surgical Disposable Nitrile rubber medical gloves are specifically designed for surgical applications. These gloves provide exceptional durability, comfort, and protection, catering to the needs of healthcare professionals. The product line includes powder-free and textured options, ensuring optimal performance in critical environments.
Unique Features for Surgical Applications
Cardinal Health’s surgical nitrile gloves are engineered for precision and safety. They offer superior resistance to punctures and chemicals, ensuring reliable protection during high-risk procedures. The gloves feature a textured surface for enhanced grip and tactile sensitivity, even in wet conditions. Their ergonomic design minimizes hand fatigue, making them suitable for extended surgical use. Cardinal Health’s focus on innovation and quality ensures its gloves meet the demanding requirements of modern surgical environments.
Manufacturer 10: Hartalega
Background and Overview
Hartalega, headquartered in Malaysia, stands as a global leader in the production of nitrile gloves. Established in 1988, the company pioneered the development of lightweight nitrile gloves, revolutionizing the industry. With a production capacity of 45 billion pairs annually, Hartalega surpasses many competitors in scale and efficiency. Its operations span 12 advanced factories, each capable of producing one million gloves daily. By leveraging local sourcing of nitrile, Hartalega ensures cost stability and mitigates supply chain disruptions. The company serves over 70 countries, maintaining a 95% inventory turnover rate to fulfill urgent orders promptly.
Certifications and Standards
Hartalega adheres to stringent international standards, ensuring the safety and quality of its surgical gloves. The following certifications highlight its commitment to excellence:
| Certification | Description |
|---|---|
| ISO | International standard for quality management systems |
| TUV | Certification for product safety and quality |
| EC | Compliance with European standards |
| OHSAS | Occupational health and safety management |
| UL | Safety certification for products |
| NMPA | National Medical Products Administration certification |
| NFPA | National Fire Protection Association standards |
| FDA 510(K) | Premarket submission to the FDA for medical devices |
These certifications underscore Hartalega’s dedication to producing reliable and compliant surgical gloves.
Product Range
Hartalega offers a diverse range of nitrile gloves tailored to meet the needs of healthcare professionals. Its product line includes thinner gloves (0.05mm) that meet ASTM puncture tests, providing cost savings without compromising safety. The company’s production lines are highly scalable, accommodating large orders efficiently. Compared to industry leaders, Hartalega’s production capacity of 45 billion pairs annually outpaces competitors like Top Glove and Kossan Rubber, each producing 30 billion pairs.
Unique Features for Surgical Applications
Hartalega’s surgical nitrile gloves combine precision, durability, and comfort. These gloves provide exceptional resistance to punctures and chemicals, ensuring safety during critical procedures. Their ultra-thin design enhances tactile sensitivity, allowing for precision in delicate tasks. A textured surface improves grip, even in wet conditions, while the ergonomic fit reduces hand fatigue during extended use. Hartalega’s innovative approach ensures its gloves meet the rigorous demands of modern surgical environments.
Hartalega’s commitment to quality, innovation, and efficiency makes it a trusted choice for healthcare professionals worldwide.
Choosing the right OEM manufacturer for surgical nitrile gloves is vital for ensuring safety and efficiency in healthcare settings. Reputable manufacturers prioritize compliance with safety standards, use high-quality materials, and focus on features like durability and puncture resistance. For example, companies like American Nitrile emphasize sustainability, while others, such as BMC Protect, excel in customer care.
The growing demand for surgical gloves, driven by factors like increased surgical procedures and the availability of raw materials, highlights the importance of selecting reliable manufacturers. The North America Medical Nitrile Gloves market, valued at USD 0.96 billion in 2021, is projected to grow significantly, reflecting the critical role of these products in healthcare.
Evaluate the listed manufacturers based on certifications, product quality, and unique features to find the best fit for your specific requirements. Selecting the right partner ensures access to OEM Surgical Disposable Nitrile rubber medical gloves that meet the highest standards of safety and performance.
FAQ
What certifications should an OEM manufacturer of surgical nitrile gloves have?
OEM manufacturers should hold ISO13485, FDA approval, and ASTM compliance. These certifications ensure product quality, safety, and adherence to international medical standards.
How can healthcare providers choose the right OEM manufacturer?
Providers should evaluate certifications, production capacity, and product features. Prioritize manufacturers offering durable gloves with chemical resistance and ergonomic designs for surgical applications.
Are nitrile gloves better than latex gloves for surgery?
Nitrile gloves offer superior puncture resistance, chemical protection, and hypoallergenic properties. These features make them ideal for surgical environments compared to latex gloves.
Post time: Mar-29-2025