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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOPE
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
PT. HALONI JANE
  SUBSTANTIALLY EQUIVALENT 1
SIAM SEMPERMED CORP. LTD.
  SUBSTANTIALLY EQUIVALENT 1

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