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., Shen Wei (Usa), Inc. and Jr Engineering & Medical Technologies (M) Sdn. Bhd..

79
Total
79
Cleared
157d
Avg days
1989
Since
79 devices
25–48 of 79
Cleared Jun 27, 2018
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K180646
Halyard Health
General Hospital · 107d
Cleared May 15, 2018
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 82d
Cleared May 02, 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K172864
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 224d
Cleared Mar 05, 2018
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K173942
Central Medicare Sdn Bhd
General Hospital · 69d
Cleared Feb 05, 2015
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K141982
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 199d
Cleared Nov 21, 2012
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
K121811
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Jun 25, 2012
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
K120336
Hartalega Sdn Bhd
General Hospital · 143d
Cleared Nov 17, 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K101436
Shen Wei (Usa), Inc.
General Hospital · 177d
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 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 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211
Allegiance Healthcare Corp.
General Hospital · 23d
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 May 22, 1989
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968
Boston Scientific Corp
General Hospital · 54d