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
265–288 of 1181
Cleared Jan 21, 2022
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211864
Siyang Jaysun Medtech Co., Ltd.
General Hospital · 219d
Cleared Jan 21, 2022
Nitrile Examination Gloves
K213044
Jiangsu Huayuan Medical Technology Co., Ltd.
General Hospital · 121d
Cleared Jan 20, 2022
Goody Gloves, Wincare, TBG Gloves
K213075
Thai Rubber Gloves Co., Ltd.
General Hospital · 119d
Cleared Jan 19, 2022
SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
K211003
Showa Best Glove, Inc.
General Hospital · 292d
Cleared Jan 19, 2022
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
K213227
Uweport, LLC
General Hospital · 112d
Cleared Jan 15, 2022
Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
K211360
Pt. Universal Gloves
General Hospital · 257d
Cleared Jan 13, 2022
Stronghold Group Nitrile Examination Glove, Powder Free
K213859
Stronghold Group, LLC
General Hospital · 34d
Cleared Jan 11, 2022
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
K212735
Xingyu Medical Tech Co., Ltd.
General Hospital · 134d
Cleared Jan 11, 2022
Medical Examination Gloves
K213168
Shandong Huiwosheng Health Technology Co.,Ltd
General Hospital · 105d
Cleared Jan 09, 2022
Powder Free Nitrile Examination Gloves, Blue Chemotest
K211666
Careglove Global Sdn. Bhd.
General Hospital · 222d
Cleared Jan 09, 2022
Powder free nitrile examination glove- black, non sterile
K212801
Hong Seng Gloves Sdn Bhd
General Hospital · 129d
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