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., Shen Wei (Usa), Inc. and Basic Medical Technology, Inc..
FDA 510(k) Cleared Polymer Patient Examination Glove Devices (Product Code LZA)
About Product Code LZA - Regulatory Context
510(k) Submission Activity
1168 total 510(k) submissions under product code LZA since 1984, with 1168 receiving FDA clearance (average review time: 117 days).
Submission volume has declined in recent years - 38 submissions in the last 24 months compared to 159 in the prior period.
FDA Review Time
FDA review times for LZA submissions have been consistent, averaging 119 days recently vs 117 days historically.
LZA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →