Medical gloves—whether examination, surgical or chemotherapy—are critical protective barriers in healthcare. Because they come into direct contact with patients & healthcare workers, the FDA enforces strict compliance standards to ensure safety & effectiveness. Manufacturers must navigate classification, performance testing & labeling requirements to legally distribute gloves in the US. Failure to comply can lead to Import Alerts, detentions & recalls.
How the FDA Classifies Medical Gloves
Understanding the FDA’s classification system helps determine the appropriate regulatory pathway:
Device Classifications
- Class I (Low Risk): Non-sterile examination gloves (latex, nitrile, vinyl, or polyethylene). Often exempt from 510(k), but must comply with Establishment Registration & Medical Device Listing.
- Class II (Moderate Risk): Surgical & chemotherapy gloves. Require 510(k) clearance to show equivalence to an approved predicate device.
Key Testing & Compliance Requirements for Medical Gloves
To pass FDA review, gloves must meet several performance & labeling benchmarks:
- ASTM & ISO Testing: Conformity to ASTM D3577 (surgical), ASTM D6319 (nitrile) & ISO 11193 for strength & durability.
- Biocompatibility Testing: Verifies that gloves don’t cause irritation or allergic reactions.
- Sterility Validation: For surgical gloves, validated sterilization processes per ISO 13485 & 21 CFR 820.
- UDI Compliance: All gloves must include a Unique Device Identifier for traceability & recall management.
Common Compliance Challenges & Solutions
Even small oversights in testing or labeling can lead to regulatory delays. Here are two examples of how compliance issues have impacted glove manufacturers:
Case Study: Import Detention Due to Quality Deficiencies
A nitrile glove manufacturer faced an Import Alert after the FDA flagged missing tensile strength data. The company had to:
- Redo ASTM performance testing.
- Update their Medical Device Listing.
- Bring in regulatory consultants to resolve detention.
Case Study: Labeling Non-Compliance on Surgical Gloves
A supplier distributing sterile surgical gloves had shipments detained due to missing sterility validation on packaging:
- Shipments were delayed, affecting revenue.
- Labeling was revised to meet FDA requirements.
- Compliance consultants were engaged to prevent future issues.
Regulatory Considerations for Medical Gloves
Keep these additional regulatory elements in mind:
- FDA User Fees: Annual fees apply, with Small Business Fee Assistance available.
- Import Alerts: Quality failures can lead to blocked shipments.
- Certificate to Foreign Government (CFG): Required to export to many international markets.
- Health Canada Licensing: An MDEL may be necessary for sales in Canada.
Maintaining Postmarket Compliance
FDA approval is just the beginning. Ongoing compliance obligations include:
- eMDR Submissions: Report all device-related adverse events.
- FOIA Requests: Use them to research similar device approvals.
- Medical Device Master File: Helps with proprietary materials & future submissions.
- Regulatory Consulting: Stay current with evolving FDA expectations.
Creating a Resilient Compliance Strategy
Manufacturers aiming to enter the US glove market must go beyond basic certification. A proactive approach to performance testing, clear labeling, validated sterility & UDI compliance helps ensure faster approval, fewer setbacks & sustained market access.
Medical Devices
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Marco Theobold A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.
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