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
337–360 of 1170
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390
Cardinal Health200, LLC
General Hospital · 115d
Cleared Aug 26, 2021
Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
K210898
Tangshan Lanhai Medical Supplies Co., Ltd.
General Hospital · 153d
Cleared Aug 24, 2021
Disposable Nitrile Examination Gloves
K210897
Shandong DS Safety Technology Co., Ltd.
General Hospital · 152d
Cleared Aug 24, 2021
Nitrile Examination Gloves
K211515
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 99d
Cleared Aug 20, 2021
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
K201857
Careplus (M) Sdn Bhd
General Hospital · 410d
Cleared Aug 20, 2021
Medical Gloves
K203622
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
General Hospital · 252d
Cleared Aug 20, 2021
Nitrile Exam Gloves, Powder Free, Blue
K211699
Hengchang (Dongying) Medical Technology Co., Ltd.
General Hospital · 78d
Cleared Aug 19, 2021
Purism Non-Sterile Powder Free Nitrile Examination Gloves
K211319
Dezhou Purism Medical Technology Co., Ltd.
General Hospital · 111d
Cleared Aug 17, 2021
Disposable Medical Nitrile Gloves
K211708
Jiangsu Health-Peace Medical Technology Co., Ltd.
General Hospital · 75d
Cleared Aug 16, 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236
Rhino Health, Inc.
General Hospital · 286d
Cleared Aug 13, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211860
Anhui Powerguard Technology Co., Ltd.
General Hospital · 58d
Cleared Aug 11, 2021
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
K202536
Yty Industry (Manjung) Sdn Bhd
General Hospital · 344d
Cleared Aug 10, 2021
Nitrile Patient Examination Glove
K210730
American Performance Polymers, LLC
General Hospital · 152d
Cleared Aug 09, 2021
Edma Synthetic Nitrile Examination Gloves
K211540
Edma Group, LLC
General Hospital · 82d
Cleared Aug 06, 2021
Nitrile Patient Examination Glove
K210725
Pingan Medical Products Co., Ltd.
General Hospital · 149d
Cleared Aug 05, 2021
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
K211075
Jiangsu Cherish Medical Technology Co., Ltd.
General Hospital · 115d
Cleared Aug 05, 2021
Nitrile Patient Examination Gloves
K211434
Zhangjiagang Huayuan Protective Equipment Co., Ltd.
General Hospital · 87d
Cleared Aug 05, 2021
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
K211608
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 72d
Cleared Aug 04, 2021
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
K211714
Hengchang (Dongying) Medical Technology Co., Ltd.
General Hospital · 62d
Cleared Aug 01, 2021
H2H Powder Free Examination Blue Glove
K211182
Ntl Innovation Co., Ltd.
General Hospital · 103d
Cleared Jul 30, 2021
Disposable Nitrile Medical Examination Glove
K210691
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 144d
Cleared Jul 30, 2021
Disposable Nitrile Examination Gloves
K211264
Shenzhen Shiqiao Science and Technology Co., Ltd.
General Hospital · 95d
Cleared Jul 29, 2021
Disposable Nitrile Medical Examination Glove
K211131
Siyang Threeguard Medical Supplies Co., Ltd.
General Hospital · 104d
Cleared Jul 29, 2021
Blue Nitrile Exam Gloves
K211341
Jiangxi Surefine Medical Co., Ltd.
General Hospital · 87d