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
385–408 of 1170
Cleared Apr 26, 2021
Powder Free Blue Nitrile Examination Glove
K203512
Vip Glove Sdn Bhd
General Hospital · 147d
Cleared Apr 21, 2021
Nitrile Glove Powder Free Blue
K210145
Changzhou Universal Medical Equipment Co., Ltd.
General Hospital · 90d
Cleared Apr 20, 2021
Disposable Nitrile Examination Gloves
K203805
Jiangsu Yanfang Medical Technology Co., Ltd.
General Hospital · 113d
Cleared Apr 16, 2021
BIOTECH Nitrile Examination Gloves
K202419
Tk Hitech Technology Co., Ltd.
General Hospital · 235d
Cleared Apr 16, 2021
Disposable Nitrile Gloves
K210276
Fujian Ercon Medical Management Co., Ltd.
General Hospital · 74d
Cleared Apr 07, 2021
Nitrile Examination Gloves
K210106
Zhenjiang Huayang Latex Products Co., Ltd.
General Hospital · 82d
Cleared Mar 31, 2021
Blue Nitrile Exam Glove, Powder Free
K210057
Real Star Medical Technology Co., Ltd.
General Hospital · 79d
Cleared Mar 30, 2021
Blue Nitrile Exam Glove, Powder Free
K210058
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
K202083
Shen Wei (Usa), Inc.
General Hospital · 241d
Cleared Mar 24, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
K202080
Shen Wei (Usa), Inc.
General Hospital · 240d
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
K202081
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593
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
K202082
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
K202086
Shen Wei (Usa), Inc.
General Hospital · 232d
Cleared Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
K202076
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
K202078
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 02, 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
K202356
Kanglongda Vietnam Protection Technology Company Limited
General Hospital · 195d
Cleared Mar 01, 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402
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
K202003
Gmp Medicare Sdn. Bhd.
General Hospital · 219d
Cleared Feb 12, 2021
LYDUS Nitrile Examination Gloves, Powder Free
K203191
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
K202622
O&M Halyard, Inc.
General Hospital · 119d
Cleared Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384
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
K202416
Kimberly Clark Corporation
General Hospital · 98d
Cleared Oct 26, 2020
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
K200150
Medline Industries, Inc.
General Hospital · 278d