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
169–192 of 1181
Cleared Sep 09, 2022
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
K220859
Careglove Global Sdn. Bhd.
General Hospital · 169d
Cleared Aug 30, 2022
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
K221164
Hong Seng Gloves Sdn Bhd
General Hospital · 130d
Cleared Aug 25, 2022
Nitrile Exam Gloves (Blue, Black)
K221143
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 127d
Cleared Aug 16, 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
K213937
O&M Halyard, Inc.
General Hospital · 243d
Cleared Aug 06, 2022
Pro Guard Nitrile Powder Free Examination Glove
K213934
Medical Glove Co., Ltd.
General Hospital · 233d
Cleared Aug 05, 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
K213993
Careglove Global Sdn. Bhd.
General Hospital · 227d
Cleared Aug 05, 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221350
Rubberex Alliance Products Sdn Bhd
General Hospital · 87d
Cleared Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K213929
O&M Halyard, Inc.
General Hospital · 228d
Cleared Aug 01, 2022
Disposable Medical Nitrile Examination Gloves
K220237
Fujian Jixiang Medical Technology Co.,Ltd
General Hospital · 186d
Cleared Jul 30, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
K221773
Onetexx Sdn Bhd
General Hospital · 39d
Cleared Jul 27, 2022
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K221269
Better Care Plastic Technology Co., Ltd.
General Hospital · 86d
Cleared Jul 27, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221271
Shandong Maida Medical Technology Co., Ltd.
General Hospital · 86d
Cleared Jul 23, 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877
Goodgloves Industries Sdn Bhd
General Hospital · 25d
Cleared Jul 19, 2022
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
K220943
Eco Medi Glove Sdn. Bhd.
General Hospital · 110d
Cleared Jul 16, 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
K221229
Zibo Blue Sail Health Technology Co., Ltd.
General Hospital · 78d
Cleared Jul 12, 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574
Grand Work Plastic Products Co., Ltd.
General Hospital · 244d
Cleared Jul 12, 2022
Nitrile Medical Examination Gloves
K221108
Anhui Fulewei Electronic Technology Co.,Ltd
General Hospital · 88d
Cleared Jul 12, 2022
Disposable Medical Nitrile Examination Gloves - Non Sterile
K221454
Guangzhou Kangling Biotechnology Co., Ltd.
General Hospital · 54d
Cleared Jul 08, 2022
Powder Free Nitrile Examination Gloves (Blue)
K220284
Kgm Gloves Sdn. Bhd.
General Hospital · 157d
Cleared Jul 08, 2022
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
K220825
American Nitrile Operations, LLC
General Hospital · 109d
Cleared Jun 29, 2022
Powder Free Nitrile Examination Glove
K220834
Daxwell, LLC
General Hospital · 99d
Cleared Jun 22, 2022
Nitrile Examination Gloves
K213739
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 205d
Cleared Jun 22, 2022
Disposable Nitrile Powder-Free Examination Gloves
K221192
Shandong Maida Medical Technology Co., Ltd.
General Hospital · 58d
Cleared Jun 17, 2022
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220431
One Glove Industrial Sdn Bhd
General Hospital · 122d