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..

1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
337–360 of 1175
Cleared Sep 02, 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778
Zhenjiang Suhui Latex Products Co., Ltd.
General Hospital · 85d
Cleared Sep 01, 2021
Disposable Medical Nitrile Gloves
K211673
Changzhou Yihua Sanitation Material Co., Ltd.
General Hospital · 92d
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