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 Jun 18, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 220d
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 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 Jun 22, 1993
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620
Acufex Microsurgical, Inc.
General Hospital · 497d
Cleared Feb 13, 1990
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093
Acufex Microsurgical, Inc.
General Hospital · 306d
Cleared Jan 04, 1990
L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
K896076
Advance Medical Designs, Inc.
General Hospital · 77d
Cleared May 22, 1989
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968
Boston Scientific Corp
General Hospital · 54d