Clearance Summary
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES received FDA 510(k) clearance under submission number K983962, sponsored by Cardinal Health,Medical Products and Services. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1999-01-08.
- Submission: K983962
- Applicant / Sponsor: Cardinal Health,Medical Products and Services
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1999-01-08
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.