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.
Recommended Actions
- Implement water leak testing program following 21 CFR § 800.20 requirements
- Maintain documentation of test results from independent U.S. laboratories
- For Level 1 detention:
- Submit 5 consecutive passing test results to be removed
- For Level 2 detention:
- Review manufacturing procedures for Quality System compliance
- Submit 10 consecutive passing test results to be removed
- 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
- Maintain proper sampling procedures:
- Test one brand/type per sample
- Include all sizes proportionally
- Sample from multiple cartons
- Document lot numbers
- 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
- Three-level detention process based on manufacturer’s import history
- 24-month Import Surveillance Cycle starts when placed on Level 1
- Evidence of Quality System compliance required for Level 3 removal
- Private lab testing can release individual shipments at Levels 1 & 2
- Manufacturers must demonstrate systemic corrections at Level 3
Relevant Guidances
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Quality System Information Requirements for Premarket Submissions
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
Related references and norms
- 21 CFR Part 800.20: Sampling plans and test methods for medical gloves
- 21 CFR Part 820: Quality System regulation
Original guidance
This post is licensed under CC BY 4.0 by the author.