Clearance Summary
Non-sterile, Powder-Free Latex Examination Glove received FDA 510(k) clearance under submission number K212309, sponsored by Sri Trang Gloves (Thailand) Public Company Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-04-08.
- Submission: K212309
- Applicant / Sponsor: Sri Trang Gloves (Thailand) Public Company Limited
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2022-04-08
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.