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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device polymer patient examination glove
Regulation Description Patient examination glove.
Definition A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product CodeLZA
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 7
BARRIERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIGHT ELEMENT SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWAY HOLDINGS SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 7
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 5
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
FLEXITECH SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
GLOVCO
  SUBSTANTIALLY EQUIVALENT 3
GRAND
  SUBSTANTIALLY EQUIVALENT 1
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 14
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 22
HIGH MOMENTUM SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
HL RUBBER INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 6
HONG XIN RUBBER PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HONGYE PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOVATIVE GLOVES CO; LTD
  SUBSTANTIALLY EQUIVALENT 4
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 7
KOSSAN LATEX
  SUBSTANTIALLY EQUIVALENT 7
LAGLOVE (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 9
LIWE TRADING
  SUBSTANTIALLY EQUIVALENT 2
MATANG MFG. SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 6
MEDTEXX MANUFACTURING SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
MULTISAFE SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
N.S. UNI-GLOVES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3
NITRITEX (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
P.T. HEALTHCARE GLOVINDO
  SUBSTANTIALLY EQUIVALENT 2
PLATINUM GLOVE INDUSTRIES SDN.BHD.
  SUBSTANTIALLY EQUIVALENT 5
PT. MAHAKARYA INTI BUANA
  SUBSTANTIALLY EQUIVALENT 4
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 9
PURTECH CLEANROOM PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QUALITY GALLANT SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
SGMP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI CHINASTAR CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MOTEX HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 18
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIAM SEMPERMED CORP. LTD.
  SUBSTANTIALLY EQUIVALENT 16
SMART GLOVE CORP. SDN BHD
  SUBSTANTIALLY EQUIVALENT 16
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 8
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERANG NUSA SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
TILLOTSON HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
ULTRAWIN SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE
  SUBSTANTIALLY EQUIVALENT 3
WRP ASIA PACIFIC
  SUBSTANTIALLY EQUIVALENT 11
YTY INDUSTRY
  SUBSTANTIALLY EQUIVALENT 11

Device Problems
No Known Device Problem 4
Reaction 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 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 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Oct-16-2015

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