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 Basic Medical Technology, Inc., Guangdong Kingfa Sci. & Tech.Co., Ltd. and Anqing Pukang Medical Technology Co., Ltd..
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 - 4 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
Recent submissions under LYZ have taken an average of 35 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 →