FDA Product Code LYY: Latex Patient Examination Glove
A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 Wrp Asia Pacific Sdn. Bhd., Shen Wei (Usa), Inc. and Kossan International Sdn Bhd.
FDA 510(k) Cleared Latex Patient Examination Glove Devices (Product Code LYY)
About Product Code LYY - Regulatory Context
510(k) Submission Activity
1954 total 510(k) submissions under product code LYY since 1988, with 1954 receiving FDA clearance (average review time: 104 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 13 in the prior period.
FDA Review Time
Recent submissions under LYY have taken an average of 166 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.
LYY devices are reviewed by the General Hospital panel. Browse all General Hospital devices →