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U.S. Department of Health and Human Services

Product Classification

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Device antimicrobial medical glove
Regulation Description Patient examination glove.
Definition A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.
Physical State A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.
Technical Method A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.
Target Area Glove
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOPI
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6250
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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