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., O&M Halyard, Inc. and Basic Medical Technology, Inc..
1168
Total
1168
Cleared
117d
Avg days
1984
Since
1168 devices
Cleared
Mar 16, 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
Shen Wei (Usa), Inc.
General Hospital
232d
Cleared
Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
Shen Wei (Usa), Inc.
General Hospital
221d
Cleared
Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Shen Wei (Usa), Inc.
General Hospital
221d
Cleared
Jan 07, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
O&M Halyard, Inc.
General Hospital
119d