Surgical Gowns and Surgical Drapes - Performance Testing and Labeling Requirements
This guidance establishes the 510(k) review requirements for surgical gowns and surgical drapes, which are devices intended to protect both surgical patients and operating room personnel from transfer of microorganisms, body fluids, and particulate material during surgical procedures. The guidance excludes surgical suits/scrub suits and surgical masks.
What You Need to Know? 👇
What are the key regulatory requirements for 510(k) submissions of surgical gowns and drapes?
Surgical gowns and drapes require premarket notification 510(k) clearance before interstate commerce. Submissions must include device description, predicate comparison, performance data, biocompatibility testing, sterility information, and comprehensive labeling meeting 21 CFR Part 801 requirements.
Which performance standards must surgical gowns and drapes meet for FDA clearance?
Key standards include ASTM ES-21/ES-22 for blood resistance, AATCC Test Method 127 for water resistance, ASTM D1424 for tear resistance, ASTM D1682 for tensile strength, and NFPA standards for fire protection in anesthetic environments.
What biocompatibility testing is required for surgical gowns and drapes?
Devices must meet Tripartite Biocompatibility Guidance or ISO 194 standards. They’re categorized as “External, Breached or Compromised Surface, Short-Term” contact. Testing may be waived if identical materials are used in legally marketed devices under same conditions.
What sterility requirements apply to sterile surgical gowns and drapes?
Sterile devices require Sterility Assurance Level (SAL) of 10⁻⁶, validated sterilization method description, appropriate packaging to maintain sterility, and if using ethylene oxide sterilization, maximum residue levels must comply with FDA proposed limits.
How should reusable surgical gowns and drapes be labeled differently from single-use devices?
Reusable devices must include reprocessing instructions (laundering and sterilization), maximum number of reprocessing cycles, tracking system for reuse cycles, and specific warnings. Single-use devices require “Sterile” marking and “Unless Package is Opened or Damaged” statement.
What information is needed for kit submissions containing surgical gowns or drapes?
Kit submissions require complete component listing, certifications that all medical device components are legally marketed or cleared, description of assembly/processing methods, evaluation of reprocessing effects on components, and consolidated labeling meeting individual component requirements.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including all models and variations
- Develop and validate testing protocols for barrier performance
- Conduct biocompatibility testing if using new materials/dyes
- Prepare detailed labeling meeting all requirements
- Document comparison to legally marketed predicate device(s)
- For sterile devices, establish and validate sterilization processes
- Prepare SMDA safety and effectiveness information
- Ensure compliance with all applicable standards
- For reusable devices, validate reprocessing instructions
- For kits, prepare additional required certifications and component documentation
Key Considerations
Non-clinical testing
- Must demonstrate effective barrier performance for minimizing microorganism passage between sterile and non-sterile areas
- Physical specifications testing (weave, thread count, weight, thickness, resistance to blood/liquid penetration, tear resistance)
- Mechanical specifications testing (strength, durability through processing cycles)
- Performance testing according to relevant standards (ASTM, AATCC methods)
Labelling
- Must include contents, size, quantity, conditions of use
- For sterile products: sterility statement and warnings
- For reusable items: reprocessing instructions including laundering and sterilization
- Lot/batch numbers
- Specific warnings/cautions regarding flammability
- Must meet 21 CFR Part 801 requirements
Biocompatibility
- Materials must be biocompatible according to Tripartite Biocompatibility Guidance or ISO 194
- Categorized as External, Breached or Compromised Surface, Short-Term
- Additional testing may be needed for new colors/dyes
Safety
- Must be lint-free
- Free of toxic ingredients
- Non-fast dyes not permitted
- Must meet fire protection requirements
- For sterile devices: SAL of 10^-6 required
Other considerations
- For sterile devices: complete sterilization validation information required
- For kits: additional requirements regarding component listing and certifications
- SMDA requirements for safety and effectiveness information
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Submission Requirements for Terminally Sterilized Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms 📂
- NFPA 702: Standards for the Use of Inhalation Anesthetics
- ASTM ES-21-1992: Standard Test Method for Resistance of Protective Clothing Materials to Synthetic Blood
- ASTM ES-22-1992: Test Method for Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens
- ASTM D737-75: Air Permeability
- AATCC 127-1989: Water Resistance: Hydrostatic Pressure Test
- AATCC 61-1989: Colorfastness to Laundering
- ASTM D1424: Elemendorf Tear
- ASTM D1682: Grab Tensile/Elongation