Clearance Summary
DUNFORD SURGEON'S STERILE GLOVES received FDA 510(k) clearance under submission number K880480, sponsored by Phillippine Radiant C/O U.S. Polymer Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-06-17.
- Submission: K880480
- Applicant / Sponsor: Phillippine Radiant C/O U.S. Polymer Industries
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1988-06-17
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.