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 O&M Halyard, Inc., Medline Industries, Inc. and Shen Wei (Usa), Inc..

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
121–144 of 1170
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
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