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
241–264 of 1170
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
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