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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device latex patient examination glove
Regulation Description Patient examination glove.
Definition A latex patient examination glove is a disposable device made of natural rubber latex 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 CodeLYY
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
ALATECH HEALTHCARE, LLC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 19
BARRIERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BETELCARE SDN BHD
  SUBSTANTIALLY EQUIVALENT 3
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIGHT ELEMENT SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWAY HOLDINGS SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 8
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 9
CML, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
  SUBSTANTIALLY EQUIVALENT 5
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DERMACARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIPPED PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
FLEXITECH SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 4
GLOVCO
  SUBSTANTIALLY EQUIVALENT 6
GX CORPORATION SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
HARTALEGA SDN BHD
  SUBSTANTIALLY EQUIVALENT 18
HIGH MOMENTUM SDN BHD
  SUBSTANTIALLY EQUIVALENT 2
INNOVATIVE GLOVES CO; LTD
  SUBSTANTIALLY EQUIVALENT 5
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KANAM LATEX INDUSTRIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
KOSSAN LATEX
  SUBSTANTIALLY EQUIVALENT 11
LAGLOVE (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 7
LIWE TRADING
  SUBSTANTIALLY EQUIVALENT 2
MATANG MFG. SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 5
MEDIPURE CORPORATION (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 8
MEDTEXX MANUFACTURING SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 3
MIRACLE-EAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MULTISAFE SDN BHD
  SUBSTANTIALLY EQUIVALENT 5
N.S. UNI-GLOVES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 4
P.T. HEALTHCARE GLOVINDO
  SUBSTANTIALLY EQUIVALENT 5
P.T. MAJA AGUNG LATEXINDO
  SUBSTANTIALLY EQUIVALENT 3
PERUSAHAAN GETAH
  SUBSTANTIALLY EQUIVALENT 8
PROTECTION GLOVES
  SUBSTANTIALLY EQUIVALENT 5
PT. HALONI JANE
  SUBSTANTIALLY EQUIVALENT 1
PT. MAHAKARYA INTI BUANA
  SUBSTANTIALLY EQUIVALENT 5
PT. MEDISAFE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PURNABINA SDN BHD
  SUBSTANTIALLY EQUIVALENT 6
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
QUALITY GALLANT SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
REGENT MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
SGMP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 25
SHANDONG YUYUAN LATEX GLOVES COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MOTEX HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEN WEI (USA), INC.
  SUBSTANTIALLY EQUIVALENT 13
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SIAM SEMPERMED CORP. LTD.
  SUBSTANTIALLY EQUIVALENT 19
SMART GLOVE CORP. SDN BHD
  SUBSTANTIALLY EQUIVALENT 8
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 6
TERANG NUSA SDN BHD
  SUBSTANTIALLY EQUIVALENT 5
TILLOTSON HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 13
ULTRAWIN SDN BHD
  SUBSTANTIALLY EQUIVALENT 4
UNIDUS CORP.
  SUBSTANTIALLY EQUIVALENT 1
WEAR SAFE
  SUBSTANTIALLY EQUIVALENT 7
WRP ASIA PACIFIC
  SUBSTANTIALLY EQUIVALENT 5
YTY INDUSTRY
  SUBSTANTIALLY EQUIVALENT 10
ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Normal 12
Unknown (for use when the device problem is not known) 12
No Known Device Problem 9
Sensitivity 5
No Information 2
Device ingredient or reagent issue 1
Total Device Problems 41

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

Recalls
Manufacturer Recall Class Date Posted
1 Adenna Inc II Jan-11-2012

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