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
265–288 of 1170
Cleared Jan 06, 2022
Penta Glove
K212847
Pentavest Holdings Sdn Bhd
General Hospital · 121d
Cleared Jan 03, 2022
Disposable Nitrile Medical Powder-free Glove
K213187
Fujian Chunhui Medical Supply Co., Ltd.
General Hospital · 96d
Cleared Dec 30, 2021
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
K212834
Siyang Threeguard Medical Supplies Co., Ltd.
General Hospital · 114d
Cleared Dec 28, 2021
ATM Glove
K213016
Phu Duc Huy Production Trading Services Corporation
General Hospital · 99d
Cleared Dec 27, 2021
Dermoaroma Disposable Nitrile Examination Glove
K212716
Chuzhou Harmony Gloves Medical Technology Co.,Ltd
General Hospital · 122d
Cleared Dec 24, 2021
Nitrile Examination Golves Powder Free
K212921
Jiangsu Standard Health Co.,Ltd
General Hospital · 101d
Cleared Dec 22, 2021
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
K211022
Central Medicare Sdn Bhd
General Hospital · 261d
Cleared Dec 22, 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914
Glovmaster Sdn. Bhd.
General Hospital · 100d
Cleared Dec 21, 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
K212613
Koon Seng Sdn Bhd
General Hospital · 125d
Cleared Dec 18, 2021
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
K211457
Ammex Corporation
General Hospital · 221d
Cleared Dec 18, 2021
USA Gloves Nitrile Powder Free Exam Gloves
K211624
Usa Gloves
General Hospital · 205d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213048
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital · 87d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213051
Yunnan Huazhiyuan Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Dec 17, 2021
Hycare Med+ Nitrile Examination Gloves
K211209
Hycare International Co., Ltd.
General Hospital · 238d
Cleared Dec 16, 2021
AT
K212645
At Glove Engineering Sdn. Bhd
General Hospital · 118d
Cleared Dec 16, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
K212898
Rimba Glove Snd Bhd
General Hospital · 97d
Cleared Dec 15, 2021
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212919
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 92d
Cleared Dec 14, 2021
Nitrile Examination Gloves (Powder free, Blue)
K213029
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
General Hospital · 84d
Cleared Dec 13, 2021
Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
K210388
Mexpo International, Inc.
General Hospital · 307d
Cleared Dec 13, 2021
Nitrile Examination Gloves
K212924
Shanxi Nacosa Medical Technology Co.,Ltd
General Hospital · 90d
Cleared Dec 13, 2021
Disposable Nitrile Powder-Free Examination Gloves
K213176
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.
General Hospital · 76d
Cleared Dec 11, 2021
Siam NTD+ Nitrile Powder-Free Examination gloves
K212085
Siam Ntd Corporation Co., Ltd.
General Hospital · 162d
Cleared Dec 11, 2021
Iconic Nitrile Glove
K212182
Iconic Medicare Sdn Bhd
General Hospital · 151d
Cleared Dec 11, 2021
Nitrile Gloves (Model: NE01)
K212840
Byd Auto Industry Company Limited
General Hospital · 95d