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
121–144 of 1181
Cleared Feb 10, 2023
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
K222129
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 207d
Cleared Feb 09, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
K223559
Nephron Pharmaceuticals Corporation
General Hospital · 73d
Cleared Feb 06, 2023
Powder Free Blue Nitrile Examination Glove
K223444
S&S Glove Corporation
General Hospital · 84d
Cleared Jan 27, 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102)
K223903
Semperit Investments Asia Pte , Ltd.
General Hospital · 30d
Cleared Jan 26, 2023
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223415
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 77d
Cleared Jan 22, 2023
Synthetic Polymer Glove - Polyethylene (Black)
K222531
Ur Industry Sdn Bhd
General Hospital · 153d
Cleared Jan 19, 2023
Disposable Nitrile Examination Glove
K223250
Yangzhou Saraguard Medical Supplies Co., Ltd.
General Hospital · 90d
Cleared Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221
Dynacare Sdn Bhd
General Hospital · 88d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
K222181
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K222907
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital · 100d
Cleared Dec 15, 2022
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
K222892
Grand Work Plastic Products Co., Ltd.
General Hospital · 83d
Cleared Dec 14, 2022
Nitrile Patient Examination Glove
K222527
Pingan Medical Products Co., Ltd.
General Hospital · 114d
Cleared Dec 11, 2022
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
K222733
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
K221626
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 184d
Cleared Dec 07, 2022
Disposable Nitrile Examination Glove
K223281
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
K222815
Zibo Lanhua Medical Packaging Material Co., Ltd.
General Hospital · 76d
Cleared Dec 04, 2022
Disposable Nitrile Examination Gloves
K223004
Jiangxi Handspro Products Solutions Co., Ltd.
General Hospital · 66d
Cleared Dec 03, 2022
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K222713
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 03, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K222715
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 03, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K222720
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 01, 2022
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
K221747
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
K221082
Rhino Health, Inc.
General Hospital · 231d
Cleared Nov 23, 2022
Nitrile Patient Examination Glove
K222534
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
General Hospital · 93d