Clearance Summary
SURGEON'S GLOVES received FDA 510(k) clearance under submission number K893522, sponsored by Thai Fuji Latex Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-01-22.
- Submission: K893522
- Applicant / Sponsor: Thai Fuji Latex Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4680
- Decision date: 1990-01-22
Classification & Regulation
This clearance is catalogued under FDA product code FGO and 21 CFR 876.4680, within the Gastroenterology, Urology review panel as a Class II device.