Clearance Summary
PERRY XTENDA CUFF SURGICAL GLOVES received FDA 510(k) clearance under submission number K905537, sponsored by Smith & Nephew Perry. 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 1991-01-11.
- Submission: K905537
- Applicant / Sponsor: Smith & Nephew Perry
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1991-01-11
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.