FDA Product Code LZA: Polymer Patient Examination Glove
Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.
These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.
LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Shen Wei (Usa), Inc., Hartalega Sdn Bhd and Hartalega NGC Sdn. Bhd..
1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
Cleared
Apr 26, 2018
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
Top Glove Sdn. Bhd.
General Hospital
213d
Cleared
Apr 13, 2018
mCare Powder-free Blue Nitrile Examination Gloves
Mercator Medical (Thailand), Ltd.
General Hospital
200d
Cleared
Feb 22, 2018
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
Koon Seng Sdn Bhd
General Hospital
307d
Cleared
Feb 20, 2018
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
Jiangsu U-Med Rubber & Plastic Products Co., Ltd.
General Hospital
139d
Cleared
Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Hartalega Sdn Bhd
General Hospital
74d
Cleared
Nov 24, 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
Shen Wei (Usa), Inc.
General Hospital
80d
Cleared
Nov 06, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
87d
Cleared
Oct 12, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
Hartalega Sdn Bhd
General Hospital
111d
Cleared
Jul 25, 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
Shen Wei (Usa), Inc.
General Hospital
341d
Cleared
Jun 30, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
Hartalega NGC Sdn. Bhd.
General Hospital
106d
Cleared
May 24, 2017
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
Shen Wei (Usa), Inc.
General Hospital
114d
Cleared
Mar 03, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
162d
Cleared
Feb 27, 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.
General Hospital
124d
Cleared
Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Hartalega Sdn Bhd
General Hospital
154d
Cleared
Feb 06, 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE
Hartalega NGC Sdn. Bhd.
General Hospital
111d
Cleared
Jan 09, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Hartalega Sdn Bhd
General Hospital
95d
Cleared
Jan 09, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Hartalega Sdn Bhd
General Hospital
95d
Cleared
Nov 17, 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
Shen Wei (Usa), Inc.
General Hospital
213d
Cleared
Oct 20, 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Wrp Asia Pacific Sdn. Bhd.
General Hospital
150d
Cleared
Oct 19, 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
Medline Industries, Inc.
General Hospital
145d
Cleared
Aug 04, 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Hartalega Sdn Bhd
General Hospital
157d
Cleared
Mar 31, 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
Hartalega NGC Sdn. Bhd.
General Hospital
255d
Cleared
Oct 21, 2015
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
Hartalega NGC Sdn. Bhd.
General Hospital
107d
Cleared
Sep 18, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
88d