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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mask, surgical
Regulation Description Surgical apparel.
Product CodeFXX
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 6
A PLUS INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CREATIVE CONTRACT (M) SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
CROSSTEX INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HONG YA NON-WOVEN PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 4
LOUIS M. GERSON CO., INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MINNESOTA MINING AND MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
MODERN HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORTH SAFETY PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
PRESTIGE AMERITECH
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WINNER INDUSTRIES (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 12
Not Applicable 3
No Information 1
No code available 1
Packaging issue 1
Foreign material present in device 1
Human-Device Interface Issue 1
Total Device Problems 20

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Maytex Corp II Jun-04-2013

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