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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device patient examination glove
Regulation Description Patient examination glove.
Product CodeFMC
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K831564  ORTHOPEDIC SURGICAL GLOVE
CML, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAGLOVE (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Torn material 16
No Known Device Problem 6
Material integrity issue 5
Out-of-box failure 4
Split 3
Device damaged prior to use 3
Crack 3
Hole in material 2
Break 2
Device operates differently than expected 2
Packaging issue 1
Defective item 1
Nonstandard device or device component 1
Tears, rips, holes in device, device material 1
Fitting problem 1
Total Device Problems 51

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