Tests Required for Surgical Gowns — FDA 510(k)

The specific tests required for a surgical gown for 510(k) submission will depend on the type of gown and its intended use. However, here are some common tests that may be required:

Surgical Gown 510K – Test Requirements.

1. Biocompatibility Testing:
   • Skin Irritation ISO – 10993-23
   • Sensitization ISO – 10993-10
   • cytotoxicity ISO – 10993-5
2. Sterilization Testing
   • ISO 10993-7 – Sterilization Residuals
3. Flammability
   • 16 CFR Part 1610 – Flammability of Textiles
4. Performance Testing
   • AATCC 127 – Hydrostatic pressure
   • AATCC 42 – Impact penetration
   • ASTM D 5034 – Tensile Strength
   • ASTM D 5733 – Tearing strength
   • ISO 7886-1 – Silicone quantity (lubricant)
   • ISO 7886-1 – Limits for Extractable Metals
   • ASTM D 1683 – Seam strength
   • ASTM F1671 – Bacteriophage Phi-X174 penetration

It’s important to note that the specific tests required may vary depending on the intended use of the gown. It’s best to consult with FDA Consultant to determine the exact testing requirements for your specific gown.

LMG Provides assistance to surgical gown manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements. Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

• Prepare 510k notification.
• Submission of 510k notification.
• FDA Agent service for 510k submission.
• Guidance in test requirements.
• Register your establishment with FDA.
• List your medical and surgical gown with FDA.