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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gown, isolation, surgical
Regulation Description Surgical apparel.
Product CodeFYC
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
A PLUS INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Contamination with biological material 1
Total Device Problems 1

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