Clearance Summary
Latex Examination Glove Powder Free (Ocean Blue and Natural White) received FDA 510(k) clearance under submission number K240266, 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 2024-09-09.
- Submission: K240266
- 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: 2024-09-09
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.