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
145–168 of 1181
Cleared Nov 20, 2022
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
K221165
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 212d
Cleared Nov 12, 2022
Nitrile Examination Gloves
K213981
Emerald Glove Manufacturing Sdn Bhd
General Hospital · 327d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
K222225
Hartalega NGC Sdn. Bhd.
General Hospital · 109d
Cleared Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898
Safesource Direct, LLC
General Hospital · 45d
Cleared Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K211816
Brightway Holdings Sdn. Bhd.
General Hospital · 509d
Cleared Nov 02, 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
K220371
Summit Glove, Inc.
General Hospital · 266d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223320
Lingshi Hongruida Health Protection Technology Co., Ltd.
General Hospital · 5d
Cleared Oct 26, 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498
Humanwell Healthcare Group Medical Supplies Co., Ltd.
General Hospital · 69d
Cleared Oct 26, 2022
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
K223235
Pt. Sintong Unigolden Glove
General Hospital · 13d
Cleared Oct 25, 2022
JR MEDIC Nitrile Examination Gloves Powder Free- Black
K221169
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 186d
Cleared Oct 21, 2022
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
K222349
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 79d
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