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
Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
Shen Wei (Usa), Inc.
General Hospital
329d
Cleared
Jun 21, 2021
Powder Free Blue Nitrile Examination Glove
Duramitt Sdn Bhd
General Hospital
133d
Cleared
Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Megine Industries Sdn Bhd
General Hospital
47d
Cleared
Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Ansell Healthcare Products, LLC
General Hospital
123d
Cleared
Jun 04, 2021
Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital
59d
Cleared
May 13, 2021
Powder Free Nitrile Examination Glove
Pastel Glove Sdn Bhd
General Hospital
94d
Cleared
May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
Central Medicare Sdn Bhd
General Hospital
214d
Cleared
May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd
General Hospital
88d
Cleared
May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
Meditech Gloves Sdn Bhd
General Hospital
53d
Cleared
Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Harbour Health, LLC
General Hospital
30d
Cleared
Apr 28, 2021
Disposable Nitrile Examination Gloves
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital
156d
Cleared
Apr 26, 2021
Powder Free Blue Nitrile Examination Glove
Vip Glove Sdn Bhd
General Hospital
147d
Cleared
Apr 21, 2021
Nitrile Glove Powder Free Blue
Changzhou Universal Medical Equipment Co., Ltd.
General Hospital
90d
Cleared
Apr 20, 2021
Disposable Nitrile Examination Gloves
Jiangsu Yanfang Medical Technology Co., Ltd.
General Hospital
113d
Cleared
Apr 16, 2021
BIOTECH Nitrile Examination Gloves
Tk Hitech Technology Co., Ltd.
General Hospital
235d
Cleared
Apr 16, 2021
Disposable Nitrile Gloves
Fujian Ercon Medical Management Co., Ltd.
General Hospital
74d
Cleared
Apr 07, 2021
Nitrile Examination Gloves
Zhenjiang Huayang Latex Products Co., Ltd.
General Hospital
82d
Cleared
Mar 31, 2021
Blue Nitrile Exam Glove, Powder Free
Real Star Medical Technology Co., Ltd.
General Hospital
79d
Cleared
Mar 30, 2021
Blue Nitrile Exam Glove, Powder Free
Great Harvest Trading Co., Ltd.
General Hospital
78d
Cleared
Mar 25, 2021
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Shen Wei (Usa), Inc.
General Hospital
241d
Cleared
Mar 24, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
Shen Wei (Usa), Inc.
General Hospital
240d
Cleared
Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
Shen Wei (Usa), Inc.
General Hospital
235d
Cleared
Mar 19, 2021
Patient Examination Gloves
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
100d
Cleared
Mar 17, 2021
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
Shen Wei (Usa), Inc.
General Hospital
233d