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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powder-free polychloroprene patient examination glove
Regulation Description Non-powdered patient examination glove.
Definition A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat 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 CodeOPC
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
HARTALEGA NGC SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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