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..
1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
Cleared
Sep 26, 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
Eco Medi Glove Sdn. Bhd.
General Hospital
156d
Cleared
Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
Hartalega Sdn Bhd
General Hospital
277d
Cleared
Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
Hartalega Sdn Bhd
General Hospital
151d
Cleared
Jul 05, 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
Multisafe Sdn. Bhd.
General Hospital
808d
Cleared
Jun 14, 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
Hartalega Sdn Bhd
General Hospital
108d
Cleared
Jun 12, 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
Riverstone Resources Sdn Bhd
General Hospital
112d
Cleared
Jun 11, 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
Ever Global (Vietnam) Enterprise Corp
General Hospital
392d
Cleared
May 10, 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
Gmp Medicare Sdn Bhd (F25)
General Hospital
232d
Cleared
Apr 30, 2018
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
Medline Industries, Inc.
General Hospital
45d
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 29, 2017
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
Ansell Healthcare Products, LLC
General Hospital
200d
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 17, 2017
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
Smart Glove Corporation Sdn. Bhd.
General Hospital
158d
Cleared
Nov 15, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital
145d
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
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
Blue Sail Medical Co.,Ltd
General Hospital
119d
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
Sep 26, 2017
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Careglove Global Sdn. Bhd.
General Hospital
85d
Cleared
Sep 20, 2017
Powder Free Nitrile Examination Gloves (Orange)
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
117d
Cleared
Sep 14, 2017
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
Semperit Investments Asia Pte , Ltd.
General Hospital
127d