| Core Product Category | Plastic surgical gloves are generally supplied as sterile, single-use medical gloves designed for surgical and other invasive procedures. | Specifications should clearly distinguish surgical gloves from examination or general-purpose medical gloves. | ISO 10282; EN 455 series |
| Common Polymer Materials | Common materials include natural rubber latex, nitrile rubber, polychloroprene, and synthetic polyisoprene. | Material selection affects elasticity, tactile sensitivity, chemical resistance, allergy considerations, and production cost. | ISO 10282; ASTM surgical glove specifications |
| Latex-Free Product Segment | Nitrile, polychloroprene, and polyisoprene gloves are used as latex-free alternatives for users with natural rubber latex sensitivity. | Purchasers should verify the material declaration and allergen-control documentation rather than relying only on marketing descriptions. | ISO 10993-1; applicable medical-device labeling rules |
| Typical Manufacturing Process | Production commonly includes former cleaning, coagulant application, polymer dipping, leaching, curing or vulcanization, surface treatment, stripping, inspection, packaging, and sterilization. | Process control at dipping, curing, and leaching stages strongly influences pinhole performance, strength, comfort, and residue levels. | ISO 10282; ISO 13485 quality-management principles |
| Surface Treatment | Powder-free gloves may use chlorination, polymer coating, or other surface treatments to reduce tackiness and improve donning. | The treatment should be validated for compatibility, residual chemicals, shelf life, and user comfort. | EN 455-3; ISO 10282 |
| Powder Status | Powder-free surgical gloves are widely specified because glove powder can contribute to contamination, irritation, and complications in clinical environments. | Purchase specifications should state “powder-free” and define acceptable residual powder or surface-treatment requirements. | ASTM D3577; EN 455-3 |
| Sterilization Methods | Ethylene oxide, gamma irradiation, and electron-beam irradiation are established methods used for sterilizing compatible medical products. | The manufacturer must validate the selected cycle, packaging compatibility, residuals, sterility assurance, and product functionality. | ISO 11135; ISO 11137; ISO 10993-7 |
| Sterility and Microbiology | Sterile surgical gloves require validated sterilization and packaging systems that maintain sterility until the point of use. | Batch records, biological indicators where applicable, packaging integrity tests, and release procedures are important audit items. | ISO 11607; ISO 11737 |
| Key Product Tests | Important tests include freedom from holes, dimensions, tensile properties, elongation, powder status, biocompatibility, packaging integrity, and sterility-related controls. | A supplier comparison should review complete test reports, sampling plans, test methods, and lot traceability. | ISO 10282; EN 455-1, EN 455-2, and EN 455-3 |
| Sizing and Design | Surgical gloves are commonly offered in half-size increments, with sizing systems that vary by manufacturer and target market. | Buyers should confirm palm width, finger length, cuff design, left-right pairing, and size tolerances using approved samples. | ISO 10282; EN 455-2 |
| Packaging Format | Sterile gloves are commonly packed as individually folded pairs in a medical-grade inner wrap or pouch, with an outer package for handling and distribution. | Packaging must protect the glove, support aseptic opening, provide labeling space, and maintain integrity throughout transport and storage. | ISO 11607; applicable market-labeling requirements |
| China Regulatory Environment | Medical gloves manufactured or marketed in China are subject to China’s medical-device regulatory system, including product registration or filing requirements applicable to the product classification. | The required regulatory pathway depends on intended use, sterility, risk classification, and the target sales market. | National Medical Products Administration; Regulations on the Supervision and Administration of Medical Devices |
| Quality Management | Medical-glove factories commonly operate documented quality systems covering incoming materials, process validation, environmental control, inspection, nonconformance handling, and traceability. | ISO 13485 certification can support supplier qualification, but it should be checked together with the factory scope and current certificate validity. | ISO 13485 |
| Private-Label and OEM Supply | China’s medical-glove supply chain supports contract manufacturing and private-label production, subject to regulatory, labeling, quality, and intellectual-property requirements. | A written technical agreement should define specifications, change notification, batch release, complaints, audits, and responsibility for market authorization. | ISO 13485; applicable importing-country regulations |
| Supplier Evaluation Criteria | Relevant evaluation factors include validated capacity, raw-material consistency, defect rates, sterilization capability, regulatory documentation, packaging performance, delivery reliability, and after-sales traceability. | The lowest unit price should not be used as the sole selection criterion for sterile surgical gloves. | ISO 13485; ISO 10282; ISO 11607 |