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U.S. Department of Health and Human Services

Product Classification

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Device surgeon's gloves
Regulation Description Surgeon's glove.
Definition A surgeon's glove is a disposable device made of natural rubber latex that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeKGO
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 510(k)
Regulation Number 878.4460
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder
Third Party Review
Accredited Persons

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