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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 10
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
JOYKEY INDUSTRIAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 12
LAC MAC, LTD.
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 10
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 3
PRECEPT MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SKLAR
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SRI SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
STACKHOUSE
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 10
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
WELMED INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Foreign material present in device 27
Hole in material 7
Material integrity issue 3
Protective measure issue 2
Material fragmentation 2
No code available 2
Other (for use when an appropriate device code cannot be identified) 2
Residue after decontamination 1
Device packaging compromised 1
Break 1
Device Cleaning Issue 1
Image display error 1
Delivered as unsterile product 1
User used incorrect product for intended use 1
Material separation 1
Not Applicable 1
No Known Device Problem 1
Packaging issue 1
Material Distortion 1
Total Device Problems 57

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 1 0 0 0 1 3 1 0 3 1
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015
3 Customed, Inc I Dec-16-2014
4 EXP Pharmaceutical Services Corp II Jul-24-2015
5 Kimberly-Clark Corporation II Nov-07-2012
6 Kimberly-Clark Corporation II Jul-16-2012
7 Kimberly-Clark Corporation II Jan-18-2011
8 Microtek Medical Inc II Mar-27-2015
9 Precept Medical Products, Inc. II Dec-28-2007
10 Stryker Instruments Div. of Stryker Corporation III Feb-10-2015
11 Stryker Instruments Div. of Stryker Corporation II Jun-06-2013
12 Stryker Instruments Div. of Stryker Corporation II Jun-14-2012

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