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
Cleared
Sep 09, 2022
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
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
Hong Seng Gloves Sdn Bhd
General Hospital
130d
Cleared
Aug 25, 2022
Nitrile Exam Gloves (Blue, Black)
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
O&M Halyard, Inc.
General Hospital
243d
Cleared
Aug 06, 2022
Pro Guard Nitrile Powder Free Examination Glove
Medical Glove Co., Ltd.
General Hospital
233d
Cleared
Aug 05, 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
Careglove Global Sdn. Bhd.
General Hospital
227d
Cleared
Aug 05, 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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
O&M Halyard, Inc.
General Hospital
228d
Cleared
Aug 01, 2022
Disposable Medical Nitrile Examination Gloves
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
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
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)
Shandong Maida Medical Technology Co., Ltd.
General Hospital
86d
Cleared
Jul 23, 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
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
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
Zibo Blue Sail Health Technology Co., Ltd.
General Hospital
78d
Cleared
Jul 12, 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., Ltd.
General Hospital
244d
Cleared
Jul 12, 2022
Nitrile Medical Examination Gloves
Anhui Fulewei Electronic Technology Co.,Ltd
General Hospital
88d
Cleared
Jul 12, 2022
Disposable Medical Nitrile Examination Gloves - Non Sterile
Guangzhou Kangling Biotechnology Co., Ltd.
General Hospital
54d
Cleared
Jul 08, 2022
Powder Free Nitrile Examination Gloves (Blue)
Kgm Gloves Sdn. Bhd.
General Hospital
157d
Cleared
Jul 08, 2022
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
American Nitrile Operations, LLC
General Hospital
109d
Cleared
Jun 29, 2022
Powder Free Nitrile Examination Glove
Daxwell, LLC
General Hospital
99d
Cleared
Jun 22, 2022
Nitrile Examination Gloves
Hangzhou Runheng Medical Co., Ltd.
General Hospital
205d
Cleared
Jun 22, 2022
Disposable Nitrile Powder-Free Examination Gloves
Shandong Maida Medical Technology Co., Ltd.
General Hospital
58d
Cleared
Jun 17, 2022
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd
General Hospital
122d