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
289–312 of 1181
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
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