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U.S. Department of Health and Human Services

Product Classification

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Device gown, isolation, surgical
Regulation Description Surgical apparel.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeFYC
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081305.pdf] 
Third Party Review
Accredited Persons

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