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.
What You Need to Know? 👇
What is FDA Import Alert #80-04 and how does it affect medical glove imports?
FDA Import Alert #80-04 is a surveillance system that allows detention without physical examination of medical gloves from manufacturers/shippers whose products repeatedly fail water leak testing. It uses a three-level escalation system based on violation history.
What are the three levels of detention for medical gloves under FDA surveillance?
Level 1 requires 5 consecutive passing shipments for removal, Level 2 requires 10 consecutive passing shipments, and Level 3 (Attachment B) requires FDA inspection or third-party audit plus systemic manufacturing corrections.
How long does an Import Surveillance Cycle last for medical glove manufacturers?
An Import Surveillance Cycle lasts 24 months from the date a manufacturer/shipper is first placed on Level 1 detention, unless the medical gloves are placed on Level 3 detention, which can extend the cycle.
What testing standards must medical gloves meet to avoid FDA detention?
Medical gloves must pass water leak testing according to 21 CFR § 800.20, which defines sampling plans, test methods, and acceptable quality levels. Independent U.S. laboratory testing using FDA methods is required for release documentation.
Can individual shipments be released while a manufacturer is on Import Alert #80-04?
Yes, individual shipments can be released from Levels 1 and 2 detention by presenting evidence from independent U.S. private laboratory testing showing the specific shipment meets FDA acceptable quality criteria per 21 CFR § 800.20.
What evidence is needed to remove a manufacturer from Level 3 detention (Attachment B)?
Removal requires demonstrating Quality System regulation compliance through FDA on-site inspection or qualified third-party audit certification, plus correcting systemic manufacturing problems that caused the apparent non-conformance with good manufacturing practices.
What You Need to Do 👇
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