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
313–336 of 1181
Cleared Nov 18, 2021
Disposable Medical Nitrile Examination Gloves (Non-sterile)
K212600
Suqian Linglian Medical Technology Co., Ltd.
General Hospital · 93d
Cleared Nov 16, 2021
Disposable Medical Nitrile Examination Gloves (non-sterile)
K212029
Taizhou Kangjian Medical Equipments Co., Ltd.
General Hospital · 140d
Cleared Nov 11, 2021
Nitrile Examination Glove (Powder free, Blue)
K212497
Jiangsu Jinlian Medical Technology Co., Ltd.
General Hospital · 94d
Cleared Nov 11, 2021
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
K212532
Crdlight Optoelectronic Technology Co., Ltd.
General Hospital · 92d
Cleared Nov 10, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210779
Shandong Shangwei Medical Products Co., Ltd.
General Hospital · 240d
Cleared Nov 07, 2021
Medical Examination Gloves (Tested for Use with Chemotherapy)
K212506
Guangdong Gymda Medical Technology Co.,Ltd
General Hospital · 90d
Cleared Nov 05, 2021
Disposable Nitrile Examination gloves
K212485
Fujian Yuanxin Safety Protection Technology Co., Ltd.
General Hospital · 88d
Cleared Nov 05, 2021
Nitrile Examination Gloves
K212551
Anhui Fine Glove Medical Technology Co., Ltd.
General Hospital · 84d
Cleared Nov 04, 2021
Disposable Nitrile Examination Glove
K212467
Inner Mongolia Boming Medical Supplies Co., Ltd.
General Hospital · 90d
Cleared Nov 02, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210777
Shandong Jieshi Medical Products Co., Ltd.
General Hospital · 232d
Cleared Nov 01, 2021
Nitrile Examination Gloves (Blue, Violet)
K211586
Lyncmed Medical Technology (Beijing) Co., Ltd.
General Hospital · 161d
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