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 Medline Industries, Inc., O&M Halyard, Inc. and Shen Wei (Usa), Inc..

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
313–336 of 1170
Cleared Oct 31, 2021
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K210588
Onetexx Sdn Bhd
General Hospital · 247d
Cleared Oct 29, 2021
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
K212308
Srirungruang Global Co., Ltd.
General Hospital · 98d
Cleared Oct 28, 2021
Disposable Nitrile Examination Gloves (Powder free, Blue)
K211581
Leping Shengde Medical Technology Company Limited
General Hospital · 160d
Cleared Oct 28, 2021
Examination gloves -Type C (Nitrile gloves)
K212290
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
General Hospital · 99d
Cleared Oct 27, 2021
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
K211604
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 155d
Cleared Oct 26, 2021
Disposable Medical Nitrile Examination Gloves
K212363
Lanhuo Medical Technology (Jiangsu) Co.,Ltd
General Hospital · 88d
Cleared Oct 25, 2021
Best Glove-Nitrile Powder Free Examination Glove
K210249
Bestsafe Glove Co., Ltd.
General Hospital · 269d
Cleared Oct 25, 2021
Disposable Nitrile Examination Glove
K212401
Inner Mongolia Cureguard Medical Technology Co., Ltd.
General Hospital · 84d
Cleared Oct 21, 2021
Medical Examination Gloves
K212311
Guangzhou Junda Gloves Co., Ltd.
General Hospital · 90d
Cleared Oct 19, 2021
Nitrile Examination Gloves
K210706
Niujian Technology Co., Ltd.
General Hospital · 223d
Cleared Oct 14, 2021
Nitrile Patient Examination Gloves
K211914
Yingxiang Glove Products Co., Ltd.
General Hospital · 115d
Cleared Oct 13, 2021
Proclean - Nitrile Powder Free Examination Gloves
K211374
Dr.Boo Company Limited
General Hospital · 162d
Cleared Oct 13, 2021
Medical Nitrile Examination Gloves
K212014
Jiangxi Ronglai Medical Technology Co., Ltd.
General Hospital · 107d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927
Fitone Latex Products Co., Ltd. Guangdong
General Hospital · 112d
Cleared Oct 08, 2021
Medical Examination Gloves
K212078
Guangdong Gymda Medical Technology Co.,Ltd
General Hospital · 98d
Cleared Oct 06, 2021
ZinRom Nitrile examination gloves
K211719
Changzhou Xingrong Medical Technology Co., Ltd.
General Hospital · 124d
Cleared Oct 05, 2021
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
K212036
Jiangsu Yanfang Medical Technology Co., Ltd.
General Hospital · 97d
Cleared Sep 29, 2021
Disposable Nitrile Gloves
K211781
Jiangsu Jinke Protective Equipment Co., Ltd.
General Hospital · 112d
Cleared Sep 21, 2021
Disposable Nitrile Examination Gloves
K211073
Foshan Kangkang Biotechnology Co., Ltd.
General Hospital · 162d
Cleared Sep 16, 2021
Blue Nitrile Examination Glove Powder Free
K211479
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 15, 2021
Disposable Nitrile Gloves
K212009
Jiangsu Shenglijie Safety Products Co., Ltd.
General Hospital · 79d
Cleared Sep 02, 2021
Nitrile Examination Gloves Powder Free (Blue)
K210868
Great Eco Glove Sdn. Bhd.
General Hospital · 163d
Cleared Sep 02, 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778
Zhenjiang Suhui Latex Products Co., Ltd.
General Hospital · 85d
Cleared Sep 01, 2021
Disposable Medical Nitrile Gloves
K211673
Changzhou Yihua Sanitation Material Co., Ltd.
General Hospital · 92d