LZA · Class I · 21 CFR 880.6250

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
481–504 of 1181
Cleared Sep 26, 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
K181066
Eco Medi Glove Sdn. Bhd.
General Hospital · 156d
Cleared Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509
Hartalega Sdn Bhd
General Hospital · 277d
Cleared Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644
Hartalega Sdn Bhd
General Hospital · 151d
Cleared Jul 05, 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
K161085
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)
K180505
Hartalega Sdn Bhd
General Hospital · 108d
Cleared Jun 12, 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452
Riverstone Resources Sdn Bhd
General Hospital · 112d
Cleared Jun 11, 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422
Ever Global (Vietnam) Enterprise Corp
General Hospital · 392d
Cleared May 10, 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
K172867
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)
K180696
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
K172923
Top Glove Sdn. Bhd.
General Hospital · 213d
Cleared Apr 13, 2018
mCare Powder-free Blue Nitrile Examination Gloves
K172930
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)
K171171
Koon Seng Sdn Bhd
General Hospital · 307d
Cleared Feb 20, 2018
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
K173228
Jiangsu U-Med Rubber & Plastic Products Co., Ltd.
General Hospital · 139d
Cleared Dec 29, 2017
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737
Ansell Healthcare Products, LLC
General Hospital · 200d
Cleared Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
K173137
Hartalega Sdn Bhd
General Hospital · 74d
Cleared Nov 24, 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678
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
K171743
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
K171873
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)
K172442
Hartalega NGC Sdn. Bhd.
General Hospital · 87d
Cleared Oct 12, 2017
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
K171782
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)
K171874
Hartalega Sdn Bhd
General Hospital · 111d
Cleared Sep 26, 2017
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
K172015
Careglove Global Sdn. Bhd.
General Hospital · 85d
Cleared Sep 20, 2017
Powder Free Nitrile Examination Gloves (Orange)
K171541
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
K171378
Semperit Investments Asia Pte , Ltd.
General Hospital · 127d