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
Cleared
Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Onetexx Sdn Bhd
General Hospital
78d
Cleared
Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
General Hospital
40d
Cleared
Oct 17, 2022
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
Zibo Langu New Material Technology Co., Ltd.
General Hospital
95d
Cleared
Oct 07, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
29d
Cleared
Oct 01, 2022
Disposable Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd.
General Hospital
5d
Cleared
Sep 30, 2022
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
Tec Gloves Industry (M) Sdn.Bhd.
General Hospital
141d
Cleared
Sep 24, 2022
Powder Free Nitrile Examination Glove
Dainam Glove Joint Stock Company
General Hospital
390d
Cleared
Sep 24, 2022
Nitrile Examination Glove, Pink Color
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
87d
Cleared
Sep 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Onetexx Sdn Bhd
General Hospital
54d
Cleared
Sep 24, 2022
Betel Gloves Nitrile Examination Glove Powder Free
Betel Care Sdn. Bhd.
General Hospital
52d
Cleared
Sep 20, 2022
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
Mezorrison Medical Technology (Dongying) Co., Ltd.
General Hospital
267d
Cleared
Sep 20, 2022
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
Inner Mongolia Cureguard Medical Technology Co., Ltd.
General Hospital
19d
Cleared
Sep 15, 2022
Nitrile Patient Examination Gloves, Powder Free
Lalan Rubbers (Pvt), Ltd.
General Hospital
190d
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