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
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
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
212d
Cleared
Nov 12, 2022
Nitrile Examination Gloves
Emerald Glove Manufacturing Sdn Bhd
General Hospital
327d
Cleared
Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
109d
Cleared
Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
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
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)
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
Lingshi Hongruida Health Protection Technology Co., Ltd.
General Hospital
5d
Cleared
Oct 26, 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
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)
Pt. Sintong Unigolden Glove
General Hospital
13d
Cleared
Oct 25, 2022
JR MEDIC Nitrile Examination Gloves Powder Free- Black
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
186d
Cleared
Oct 21, 2022
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
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
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