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
409–432 of 1170
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
Cleared Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K200581
Hartalega NGC Sdn. Bhd.
General Hospital · 51d
Cleared Apr 15, 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K200181
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 82d
Cleared Apr 10, 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
K200072
Kimberly Clark Corporation
General Hospital · 87d
Cleared Apr 09, 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Apr 09, 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
K200539
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 37d
Cleared Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
K200019
Hartalega NGC Sdn. Bhd.
General Hospital · 94d
Cleared Mar 20, 2020
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
K193121
Eco Medi Glove Sdn. Bhd.
General Hospital · 129d
Cleared Mar 20, 2020
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
K193581
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 88d
Cleared Mar 17, 2020
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
K191753
Medline Industries, Inc.
General Hospital · 260d
Cleared Mar 13, 2020
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K192241
O&M Haylard, Inc.
General Hospital · 207d
Cleared Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
K192333
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 150d