Clearance Summary
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE received FDA 510(k) clearance under submission number K000421, sponsored by Ssl Americas, Inc. (Regent Medical). 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 2000-08-14.
- Submission: K000421
- Applicant / Sponsor: Ssl Americas, Inc. (Regent Medical)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2000-08-14
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.