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..

1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
409–432 of 1181
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
Cleared Sep 22, 2020
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
K200843
O&M Halyard, Inc.
General Hospital · 175d
Cleared Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
K192111
Top Glove Sdn. Bhd.
General Hospital · 395d
Cleared Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K201772
Hartalega NGC Sdn. Bhd.
General Hospital · 57d
Cleared Aug 20, 2020
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
K200093
Anhui Lntco Medical Products Co., Ltd.
General Hospital · 217d
Cleared Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
K201530
Hartalega NGC Sdn. Bhd.
General Hospital · 58d
Cleared Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K201531
Hartalega Sdn Bhd
General Hospital · 58d
Cleared Aug 04, 2020
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff
K193666
Medline Industries, Inc.
General Hospital · 217d
Cleared Jul 13, 2020
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
K200960
Medline Industires, Inc.
General Hospital · 94d
Cleared Jun 19, 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
K192954
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 242d
Cleared Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
K200671
Ansell Healthcare Products, LLC
General Hospital · 98d
Cleared Jun 06, 2020
mCare(R) Powder Free Nitrile Orange Examination Gloves
K200967
Mercator Medical (Thailand), Ltd.
General Hospital · 57d
Cleared Jun 05, 2020
Latex Examination Powder Free Glove, Aloe Vera
K193150
Top Glove Sdn. Bhd.
General Hospital · 205d
Cleared May 01, 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
K200453
Yty Industry (Manjung) Sdn Bhd
General Hospital · 67d