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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device surgeon's gloves
Regulation Description Surgeon's glove.
Definition A surgeon's glove is a disposable device made of natural rubber latex that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product CodeKGO
Regulation Number 878.4460
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN BANTEX CORP
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 25
APEX
  SUBSTANTIALLY EQUIVALENT 1
BARRIERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIGHTWAY HOLDINGS SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 27
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
HUTCHINSON
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 10
KANAM LATEX INDUSTRIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 3
LAGLOVE (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 4
MARINA MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
MEDLINE
  SUBSTANTIALLY EQUIVALENT 4
METACURE SURGICAL GLOVES SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
P.T. MAJA AGUNG LATEXINDO
  SUBSTANTIALLY EQUIVALENT 2
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
REGENT MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI MOTEX HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 1
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMART GLOVE CORP. SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERANG NUSA SDN BHD
  SUBSTANTIALLY EQUIVALENT 15
TILLOTSON HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 2
WEAR SAFE
  SUBSTANTIALLY EQUIVALENT 2
WRP ASIA PACIFIC
  SUBSTANTIALLY EQUIVALENT 15
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 4
Cross reactivity 1
Improper or incorrect procedure or method 1
Device operates differently than expected 1
Total Device Problems 7

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 1 0 2 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Healthcare Products LLC II Dec-15-2010
2 Ansell Healthcare Products LLC II Jul-24-2009
3 Cardinal Health II Jun-18-2009
4 Terang Nusa Sdn Bhd II Jan-25-2007

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