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
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 Nov 28, 2017
Orange Non Sterile Powder Free Nitrile Examination Gloves
K172642
Central Medicare Sdn Bhd
General Hospital · 88d
Cleared Nov 13, 2017
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K172525
Central Medicare Sdn Bhd
General Hospital · 84d
Cleared Jul 24, 2017
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
K162858
Careplus (M) Sdn Bhd
General Hospital · 285d
Cleared Mar 31, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
K162186
Brightway Holdings Sdn. Bhd.
General Hospital · 239d
Cleared Mar 22, 2017
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
K163017
Gmp Medicare Sdn. Bhd.
General Hospital · 145d
Cleared Feb 13, 2017
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
K163146
Hebei Hongsen Plastics Technology Co, Ltd.
General Hospital · 96d
Cleared Sep 06, 2016
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
K160709
Halyard Health
General Hospital · 176d
Cleared May 02, 2016
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
K151390
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 342d
Cleared Apr 21, 2016
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
K152222
Gmp Medicare Sdn Bhd (F25)
General Hospital · 258d
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 Sep 20, 2012
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
K121926
Northstar Healthcare Holdings
General Hospital · 80d
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 29, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
K102790
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 63d
Cleared Nov 19, 2010
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K101822
Sgmp Co., Ltd.
General Hospital · 142d
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 Nov 02, 2009
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K091643
Gx Corporation Sdn Bhd
General Hospital · 151d
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