Ensuring Quality & Compliance for Medical-Grade Gloves

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.