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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gown, non-sterile, non-isolation, intended to provide moderate or high barrier protection
Regulation Description Surgical apparel.
Definition A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.
Product CodeQPC
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
AZAC GROUP
  SUBSTANTIALLY EQUIVALENT 1
CADILLAC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONG NAI GARMENT CORPORATION (DONAGAMEX)
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KENPAX INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
POLYCONVERSIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2

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