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 O&M Halyard, Inc., Medline Industries, Inc. and Shen Wei (Usa), Inc..
1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
Cleared
Dec 15, 2022
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd.
General Hospital
83d
Cleared
Dec 14, 2022
Nitrile Patient Examination Glove
Pingan Medical Products Co., Ltd.
General Hospital
114d
Cleared
Dec 11, 2022
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
Inner Mongolia Boming Medical Supplies Co., Ltd.
General Hospital
93d
Cleared
Dec 07, 2022
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
184d
Cleared
Dec 07, 2022
Disposable Nitrile Examination Glove
Anhui Kindguard Medical Supplies Technology Co., Ltd.
General Hospital
43d
Cleared
Dec 04, 2022
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Zibo Lanhua Medical Packaging Material Co., Ltd.
General Hospital
76d
Cleared
Dec 04, 2022
Disposable Nitrile Examination Gloves
Jiangxi Handspro Products Solutions Co., Ltd.
General Hospital
66d
Cleared
Dec 03, 2022
White Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
General Hospital
86d
Cleared
Dec 03, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
General Hospital
86d
Cleared
Dec 03, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
General Hospital
86d
Cleared
Dec 01, 2022
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Fitone Latex Products Co., Ltd. Guangdong
General Hospital
168d
Cleared
Nov 30, 2022
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
Rhino Health, Inc.
General Hospital
231d
Cleared
Nov 23, 2022
Nitrile Patient Examination Glove
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
General Hospital
93d
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