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
145–168 of 1170
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
K222298
Onetexx Sdn Bhd
General Hospital · 78d
Cleared Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K222721
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
K222074
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
K222714
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 29d
Cleared Oct 01, 2022
Disposable Nitrile Examination Glove
K222937
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 5d
Cleared Sep 30, 2022
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
K221378
Tec Gloves Industry (M) Sdn.Bhd.
General Hospital · 141d
Cleared Sep 24, 2022
Powder Free Nitrile Examination Glove
K212751
Dainam Glove Joint Stock Company
General Hospital · 390d
Cleared Sep 24, 2022
Nitrile Examination Glove, Pink Color
K221887
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
K222294
Onetexx Sdn Bhd
General Hospital · 54d
Cleared Sep 24, 2022
Betel Gloves Nitrile Examination Glove Powder Free
K222342
Betel Care Sdn. Bhd.
General Hospital · 52d
Cleared Sep 20, 2022
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
K214056
Mezorrison Medical Technology (Dongying) Co., Ltd.
General Hospital · 267d
Cleared Sep 20, 2022
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
K222642
Inner Mongolia Cureguard Medical Technology Co., Ltd.
General Hospital · 19d
Cleared Sep 15, 2022
Nitrile Patient Examination Gloves, Powder Free
K220697
Lalan Rubbers (Pvt), Ltd.
General Hospital · 190d
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