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U.S. Department of Health and Human Services

Product Classification

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Device powdered latex patient examination glove
Regulation Description Patient examination glove.
Definition A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Physical State A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Technical Method A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Target Area A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOPE
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6250
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
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  • Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder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 Not Third Party Eligible
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