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
217–240 of 1170
Cleared Apr 09, 2022
Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
K220401
Riverstone Resources Sdn Bhd
General Hospital · 57d
Cleared Apr 03, 2022
ELAZ Nitrile Powder Free Examination Glove
K213604
Protect Gloves Co., Ltd.
General Hospital · 139d
Cleared Apr 03, 2022
Medical Nitrile Examination Gloves
K220066
Hunan Zhenheyikang Medical Instrument Co., Ltd.
General Hospital · 83d
Cleared Apr 02, 2022
Nitrile Examination Gloves
K220343
Nb Medical Co., Ltd.
General Hospital · 54d
Cleared Mar 31, 2022
Nitrile Examination Gloves
K213843
Dong Tai City Huayi Gloves Co., Ltd.
General Hospital · 112d
Cleared Mar 28, 2022
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
K213662
Taishan Weibang Medical Equipment Co., Ltd.
General Hospital · 126d
Cleared Mar 26, 2022
Clover Glove
K213729
Clover Glove Company Limited
General Hospital · 120d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
K220215
Ksg Medicare Sdn. Bhd.
General Hospital · 59d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Gloves, Orange
K220229
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 58d
Cleared Mar 25, 2022
Medical nitrile examination gloves (Model: JL001)
K213848
Guangdong Jiali Pharmaceutical Co.,Ltd
General Hospital · 105d
Cleared Mar 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K212916
Rimba Glove Sdn Bhd
General Hospital · 192d
Cleared Mar 24, 2022
Disposable Medical Synthetic Nitrile Examination Gloves
K220354
Niujian Technology Co., Ltd.
General Hospital · 44d
Cleared Mar 22, 2022
Powder Free Blue Nitrile Examination Gloves
K213678
Lienteh Technology Sdn Bhd
General Hospital · 120d
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