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U.S. Department of Health and Human Services

Product Classification

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Device powder, dusting, surgical
Regulation Description Absorbable powder for lubricating a surgeon's glove.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeKGP
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools (PRSB1)
Submission Type PMA
Regulation Number 878.4480
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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