Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
This guidance provides comprehensive recommendations for manufacturers, importers, and distributors of medical gloves regarding premarket notification (510(k)) submissions, quality system requirements, labeling, and compliance activities. It covers both patient examination gloves and surgeon's gloves made from natural rubber latex and synthetic materials.
Recommended Actions
- Establish and maintain a quality system that meets 21 CFR 820 requirements
- Submit 510(k) notifications for new gloves or significant changes to existing gloves
- Implement testing programs for:
- Physical properties
- Barrier integrity
- Biocompatibility
- Protein content (latex)
- Powder residue (powder-free)
- Stability/shelf-life
- Develop compliant labeling that includes all required elements
- Validate manufacturing processes and establish process controls
- Implement environmental and contamination controls during manufacturing
- Establish incoming material, in-process, and finished device testing procedures
- Maintain complaint handling and adverse event reporting systems
- For imports, ensure compliance with FDA import requirements
- Maintain documentation of conformance to recognized consensus standards
Key Considerations
Non-clinical testing
- Water leak testing required per 21 CFR 800.20
- Physical properties testing (tensile strength, elongation, dimensions) per applicable ASTM standards
- Powder residue testing for powder-free claims
- Protein content testing for latex gloves
- Shelf-life/stability testing to support expiration dating
Human Factors
- Evaluation of donning ability, strength, thickness, feel, size, shape, texture, holding ability, tactile sensitivity, lack of fatigue, lack of irritation
- Assessment of comfort and usability
Labeling
- Must include basic information per 21 CFR 801
- Natural rubber latex warning statement required if applicable
- Powder/powder-free status must be indicated
- Expiration dating if claimed
- Size, lot number, manufacturer information
- Single use only statement
- Sterility status for surgical gloves
Biocompatibility
- Primary skin irritation testing required
- Dermal sensitization testing required
- Testing must be on finished, packaged gloves
- Additional testing needed for any additives (colors, scents, etc.)
Safety
- Must meet barrier integrity requirements
- Controls needed for manufacturing materials/residues
- Protein levels must be controlled for latex gloves
- Sterility required for surgical gloves
Other considerations
- Quality System requirements per 21 CFR 820
- Process validation requirements
- Environmental controls during manufacturing
- Incoming material controls
- In-process and finished device testing
- Complaint handling procedures
- Import requirements if applicable
Relevant Guidances
- Import Surveillance and Detention of Medical Gloves that Fail Water Leak Testing
- Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Related references and norms
- ASTM D3577: Standard Specification for Rubber Surgical Gloves
- ASTM D3578: Standard Specification for Rubber Examination Gloves
- ASTM D5250: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
- ASTM D6319: Standard Specification for Nitrile Examination Gloves
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5712: Standard Test Method for Analysis of Aqueous Extractable Protein
- ISO 10282: Single-use surgical rubber gloves - Specification
- ISO 11193: Single-use medical examination gloves - Specification
Original guidance
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