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
385–408 of 1181
Cleared Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
K202085
Shen Wei (Usa), Inc.
General Hospital · 329d
Cleared Jun 21, 2021
Powder Free Blue Nitrile Examination Glove
K210375
Duramitt Sdn Bhd
General Hospital · 133d
Cleared Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
K211310
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
K210401
Ansell Healthcare Products, LLC
General Hospital · 123d
Cleared Jun 04, 2021
Nitrile Patient Examination Gloves
K211028
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital · 59d
Cleared May 13, 2021
Powder Free Nitrile Examination Glove
K210369
Pastel Glove Sdn Bhd
General Hospital · 94d
Cleared May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036
Central Medicare Sdn Bhd
General Hospital · 214d
Cleared May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366
Onetexx Sdn Bhd
General Hospital · 88d
Cleared May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755
Meditech Gloves Sdn Bhd
General Hospital · 53d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
K210944
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 28, 2021
Disposable Nitrile Examination Gloves
K203436
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital · 156d
Cleared Apr 26, 2021
Powder Free Blue Nitrile Examination Glove
K203512
Vip Glove Sdn Bhd
General Hospital · 147d
Cleared Apr 21, 2021
Nitrile Glove Powder Free Blue
K210145
Changzhou Universal Medical Equipment Co., Ltd.
General Hospital · 90d
Cleared Apr 20, 2021
Disposable Nitrile Examination Gloves
K203805
Jiangsu Yanfang Medical Technology Co., Ltd.
General Hospital · 113d
Cleared Apr 16, 2021
BIOTECH Nitrile Examination Gloves
K202419
Tk Hitech Technology Co., Ltd.
General Hospital · 235d
Cleared Apr 16, 2021
Disposable Nitrile Gloves
K210276
Fujian Ercon Medical Management Co., Ltd.
General Hospital · 74d
Cleared Apr 07, 2021
Nitrile Examination Gloves
K210106
Zhenjiang Huayang Latex Products Co., Ltd.
General Hospital · 82d
Cleared Mar 31, 2021
Blue Nitrile Exam Glove, Powder Free
K210057
Real Star Medical Technology Co., Ltd.
General Hospital · 79d
Cleared Mar 30, 2021
Blue Nitrile Exam Glove, Powder Free
K210058
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
K202083
Shen Wei (Usa), Inc.
General Hospital · 241d
Cleared Mar 24, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
K202080
Shen Wei (Usa), Inc.
General Hospital · 240d
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
K202081
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593
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
K202082
Shen Wei (Usa), Inc.
General Hospital · 233d