FDA Product Code LYZ: Vinyl Patient Examination Glove
A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Medline Industries, Inc. and Baxter Healthcare Corp.
FDA 510(k) Cleared Vinyl Patient Examination Glove Devices (Product Code LYZ)
About Product Code LYZ - Regulatory Context
510(k) Submission Activity
799 total 510(k) submissions under product code LYZ since 1989, with 799 receiving FDA clearance (average review time: 98 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 7 in the prior period.
FDA 510(k) Review Time - LYZ Product Code
Recent submissions under LYZ have taken an average of 41 days to reach a decision - down from 98 days historically, suggesting improved FDA processing for this classification.
LYZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →