Clearance Summary
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES received FDA 510(k) clearance under submission number K050181, sponsored by Medigloves , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-04-13.
- Submission: K050181
- Applicant / Sponsor: Medigloves , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2005-04-13
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.