Clearance Summary
HPI ORTHO SURGEONS' GLOVE received FDA 510(k) clearance under submission number K894828, sponsored by Tillotson Rubber Co., Inc.. 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 1990-05-07.
- Submission: K894828
- Applicant / Sponsor: Tillotson Rubber Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1990-05-07
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.