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Import Surveillance and Detention of Medical Gloves that Fail Water Leak Testing

This guidance outlines FDA's strategy for surveillance and detention of imported surgeons' and patient examination gloves (medical gloves) that fail to meet FDA's minimum acceptable quality criteria through water leak testing. It establishes a risk-based, three-level detention process for managing imports from manufacturers/shippers with a history of quality issues.

  1. Implement water leak testing program following 21 CFR § 800.20 requirements
  2. Maintain documentation of test results from independent U.S. laboratories
  3. For Level 1 detention:
    • Submit 5 consecutive passing test results to be removed
  4. For Level 2 detention:
    • Review manufacturing procedures for Quality System compliance
    • Submit 10 consecutive passing test results to be removed
  5. For Level 3 detention:
    • Conduct full Quality System assessment
    • Implement corrective actions for systemic issues
    • Obtain FDA inspection or third-party audit
    • Submit evidence of Quality System compliance
  6. Maintain proper sampling procedures:
    • Test one brand/type per sample
    • Include all sizes proportionally
    • Sample from multiple cartons
    • Document lot numbers
  7. Keep records of import history and detention status to track Import Surveillance Cycle

Key Considerations

Non-clinical testing

  • Water leak testing required as per 21 CFR § 800.20
  • Testing must be performed by independent qualified U.S. testing laboratories
  • Testing at manufacturing facility or by labs in country of origin not acceptable
  • Only one brand/type of glove should be included in a single test sample
  • All sizes should be represented proportionally in samples

Safety

  • Glove defects like holes compromise barrier effectiveness against blood/fluid-borne pathogens
  • Defective gloves present potential significant health hazard

Other considerations

  • 21 CFR Part 800.20: Sampling plans and test methods for medical gloves
  • 21 CFR Part 820: Quality System regulation

Original guidance

  • Import Surveillance and Detention of Medical Gloves that Fail Water Leak Testing
  • HTML / PDF
  • Issue date: 2008-07-11
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: d86c889405b15196bb7b3a66dd704531
This post is licensed under CC BY 4.0 by the author.