LZC · Class I · 21 CFR 880.6250

FDA Product Code LZC: Medical Glove, Specialty

A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.

Leading manufacturers include Wrp Asia Pacific Sdn. Bhd., Central Medicare Sdn Bhd and Perusahaan Getah Asas Sdn. Bhd..

79
Total
79
Cleared
157d
Avg days
1989
Since
79 devices
49–72 of 79
Cleared Jul 31, 2009
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K083408
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 255d
Cleared Jul 31, 2009
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
K083410
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 255d
Cleared Jul 29, 2009
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
K083409
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 253d
Cleared Jun 18, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 220d
Cleared Dec 23, 2008
BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
K081971
Nitritex (M) Sdn. Bhd.
General Hospital · 166d
Cleared Jul 14, 2008
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K081089
Kimberly-Clark Corp.
General Hospital · 89d
Cleared Mar 12, 2008
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR
K072197
Metacure Surgical Gloves Sdn Bhd
General Hospital · 218d
Cleared Feb 27, 2007
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
K062764
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 165d
Cleared Dec 16, 2004
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
K042805
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 65d
Cleared May 07, 2004
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789
Cardinalhealth
General Hospital · 155d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
K032444
Cardinalhealth
General Hospital · 97d
Cleared Oct 22, 2003
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 82d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Nov 01, 1999
ABSOGEL CHEMOTHERAPHY GLOVES
K990677
Ampri Rubberware Industries Sdn Bhd
General Hospital · 244d
Cleared Aug 30, 1999
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
K992162
Safeskin Corp.
General Hospital · 66d
Cleared Dec 23, 1998
PROGUARD, RR-1, RR-2
K982832
Emerson & Co. Srl
General Hospital · 133d
Cleared Aug 25, 1997
NITRILE GLOVES
K970135
Sage Products, Inc.
General Hospital · 222d
Cleared Dec 29, 1994
GUARDIAN II GLOVE
K945577
Guardian Group, Inc.
General Hospital · 45d
Cleared Jul 08, 1994
GUARDIAN GLOVE
K942313
Guardian Group, Inc.
General Hospital · 56d
Cleared Jun 22, 1993
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620
Acufex Microsurgical, Inc.
General Hospital · 497d
Cleared Mar 22, 1991
NEEDLESTICK PROTECTIVE GLOVE
K905527
Medev Corp.
General Hospital · 102d
Cleared Jan 30, 1991
STAT(TM) GLOVE
K905177
Success Builders Intl., Inc.
General Hospital · 72d
Cleared Oct 26, 1990
AUKUFLEX(TM) RADIATION RESISTANT GLOVES
K903142
Aukland Mfg., Inc.
General Hospital · 101d
Cleared Mar 27, 1990
PB PLUS LEAD LATEX GLOVES
K896759
Sistem Med-Pro (M) Sdn Bhd
General Hospital · 116d