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
Cleared
Apr 26, 2021
Powder Free Blue Nitrile Examination Glove
Vip Glove Sdn Bhd
General Hospital
147d
Cleared
Apr 21, 2021
Nitrile Glove Powder Free Blue
Changzhou Universal Medical Equipment Co., Ltd.
General Hospital
90d
Cleared
Apr 20, 2021
Disposable Nitrile Examination Gloves
Jiangsu Yanfang Medical Technology Co., Ltd.
General Hospital
113d
Cleared
Apr 16, 2021
BIOTECH Nitrile Examination Gloves
Tk Hitech Technology Co., Ltd.
General Hospital
235d
Cleared
Apr 16, 2021
Disposable Nitrile Gloves
Fujian Ercon Medical Management Co., Ltd.
General Hospital
74d
Cleared
Apr 07, 2021
Nitrile Examination Gloves
Zhenjiang Huayang Latex Products Co., Ltd.
General Hospital
82d
Cleared
Mar 31, 2021
Blue Nitrile Exam Glove, Powder Free
Real Star Medical Technology Co., Ltd.
General Hospital
79d
Cleared
Mar 30, 2021
Blue Nitrile Exam Glove, Powder Free
Great Harvest Trading Co., Ltd.
General Hospital
78d
Cleared
Mar 25, 2021
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Shen Wei (Usa), Inc.
General Hospital
241d
Cleared
Mar 24, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
Shen Wei (Usa), Inc.
General Hospital
240d
Cleared
Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
Shen Wei (Usa), Inc.
General Hospital
235d
Cleared
Mar 19, 2021
Patient Examination Gloves
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
100d
Cleared
Mar 17, 2021
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
Shen Wei (Usa), Inc.
General Hospital
233d
Cleared
Mar 16, 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
Shen Wei (Usa), Inc.
General Hospital
232d
Cleared
Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
Shen Wei (Usa), Inc.
General Hospital
221d
Cleared
Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Shen Wei (Usa), Inc.
General Hospital
221d
Cleared
Mar 02, 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Kanglongda Vietnam Protection Technology Company Limited
General Hospital
195d
Cleared
Mar 01, 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
Jiangsu Tianshuo Medical Products Co., Ltd.
General Hospital
192d
Cleared
Feb 24, 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Gmp Medicare Sdn. Bhd.
General Hospital
219d
Cleared
Feb 12, 2021
LYDUS Nitrile Examination Gloves, Powder Free
Nathan Trading Co., Ltd.
General Hospital
108d
Cleared
Jan 07, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
O&M Halyard, Inc.
General Hospital
119d
Cleared
Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
Hi-Care Thai Gloves Co. , Ltd.
General Hospital
104d
Cleared
Nov 30, 2020
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Kimberly Clark Corporation
General Hospital
98d
Cleared
Oct 26, 2020
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
Medline Industries, Inc.
General Hospital
278d