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
289–312 of 1170
Cleared Dec 10, 2021
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
K212349
Medi Legion Sdn.Bhd
General Hospital · 135d
Cleared Dec 10, 2021
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850
Thai Rubber Industry Company Limited
General Hospital · 94d
Cleared Dec 10, 2021
Nitrile Examination Gloves
K212922
Hsk Medical Apparatus Foshan China Co., Ltd.
General Hospital · 87d
Cleared Dec 09, 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371
Anhui Xinyisheng Medical Technology Co.,Ltd
General Hospital · 58d
Cleared Dec 04, 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 115d
Cleared Dec 02, 2021
Nitrile disposable examination gloves
K212578
Xingyu Medical Tech Co., Ltd.
General Hospital · 108d
Cleared Dec 02, 2021
powder free nitrile examination glove - white, non-sterile
K212802
Hong Seng Gloves Sdn Bhd
General Hospital · 91d
Cleared Dec 01, 2021
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212789
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 91d
Cleared Dec 01, 2021
Powder free nitrile examination glove- blue, non-sterile
K212804
Hong Seng Gloves Sdn Bhd
General Hospital · 90d
Cleared Nov 26, 2021
Nitrile Examination Gloves
K212722
Wuhan Huirui Technology Co., Ltd.
General Hospital · 91d
Cleared Nov 22, 2021
Non-sterile Powder Free Nitrile Examination Gloves
K210990
Rubberex Alliance Sdn Bhd
General Hospital · 234d
Cleared Nov 19, 2021
HALYARD Flexaprene Green Powder-Free Exam Glove
K211063
O&M Halyard, Inc.
General Hospital · 224d
Cleared Nov 19, 2021
Disposable Nitrile Examination Glove
K212661
Inner Mongolia Cureguard Medical Technology Co., Ltd.
General Hospital · 88d
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