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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device garment, protective, for incontinence
Regulation Description Protective garment for incontinence.
Product CodeEYQ
Regulation Number 876.5920
Device Class 1


Premarket Reviews
ManufacturerDecision
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 4
Break 3
Material separation 2
Unknown (for use when the device problem is not known) 2
Total Device Problems 11

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