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
241–264 of 1181
Cleared Mar 18, 2022
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
K220228
Shandong Blue Sail Health Technology Co., Ltd.
General Hospital · 50d
Cleared Mar 15, 2022
Disposable Nitrile Examination Glove
K213121
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 169d
Cleared Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
K212148
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 10, 2022
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K213373
Smart Glove Corporation Sdn. Bhd.
General Hospital · 149d
Cleared Mar 09, 2022
Disposable Medical Nitrile gloves
K213851
Guangdong Xingcan Brothers Medical Technology Co.,Ltd
General Hospital · 89d
Cleared Mar 04, 2022
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
K210330
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 393d
Cleared Mar 04, 2022
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
K211808
Dongguan Grinvald Technology Co., Ltd.
General Hospital · 266d
Cleared Feb 28, 2022
Disposable Nitrile Examination Gloves
K212833
Chifeng Huawei Medical Science&Technology Co., Ltd.
General Hospital · 174d
Cleared Feb 21, 2022
TMG Nitrile Powder Free Examination Glove
K213500
Thai Medical Glove Co., Ltd.
General Hospital · 112d
Cleared Feb 21, 2022
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
K213548
Mercator Medical (Thailand), Ltd.
General Hospital · 105d
Cleared Feb 20, 2022
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K220232
Megine Industries Sdn Bhd
General Hospital · 24d
Cleared Feb 19, 2022
Powder Free Nitrile Examination Gloves (White, Blue and Black)
K212998
Alcatron Gloves Factory
General Hospital · 152d
Cleared Feb 19, 2022
EONS Nitrile Examination Gloves Powder Free
K213286
Eons Gloves (Thailand) Co., Ltd.
General Hospital · 141d
Cleared Feb 19, 2022
Medical nitrile examination gloves (Model: SH001)
K213600
Jiangxi Sanhao Medical Instruments Co.,Ltd
General Hospital · 96d
Cleared Feb 19, 2022
Disposable Medical Nitrile Examination Gloves
K213912
Jiangsu Maolin Medical Technology Co., Ltd.
General Hospital · 66d
Cleared Feb 19, 2022
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
K214110
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 52d
Cleared Feb 18, 2022
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
K213306
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 137d
Cleared Feb 18, 2022
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
K213440
Luliang Hongruida Health Protection Technology Co., Ltd.
General Hospital · 116d
Cleared Feb 18, 2022
Nitrile Examination Gloves (Model: ZMG1351)
K213688
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 87d
Cleared Feb 17, 2022
Amazing+
K212586
Amazing Rubber Products Pvt, Ltd.
General Hospital · 185d
Cleared Feb 17, 2022
Powder Free Blue Nitrile Examination Gloves
K213107
Novid Ppe Sdn. Bhd.
General Hospital · 146d
Cleared Feb 08, 2022
O'Star Nitrile Examination Gloves Powder Free
K213058
Star Investment and Trade Joint Stock Company
General Hospital · 139d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
K213142
Shen Wei (Usa), Inc.
General Hospital · 123d
Cleared Jan 23, 2022
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
K210463
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 341d