Clearance Summary
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING received FDA 510(k) clearance under submission number K113707, sponsored by Cardinal Health-Medical Products and Services. 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 2012-04-27.
- Submission: K113707
- Applicant / Sponsor: Cardinal Health-Medical Products and Services
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2012-04-27
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.