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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.

  1. Establish and maintain a quality system that meets 21 CFR 820 requirements
  2. Submit 510(k) notifications for new gloves or significant changes to existing gloves
  3. Implement testing programs for:
    • Physical properties
    • Barrier integrity
    • Biocompatibility
    • Protein content (latex)
    • Powder residue (powder-free)
    • Stability/shelf-life
  4. Develop compliant labeling that includes all required elements
  5. Validate manufacturing processes and establish process controls
  6. Implement environmental and contamination controls during manufacturing
  7. Establish incoming material, in-process, and finished device testing procedures
  8. Maintain complaint handling and adverse event reporting systems
  9. For imports, ensure compliance with FDA import requirements
  10. 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

  • 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

  • Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
  • HTML / PDF
  • Issue date: 2008-01-22
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 2e4dad48bb298f3bbd0a8f89143a03ee
This post is licensed under CC BY 4.0 by the author.