Clearance Summary
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING received FDA 510(k) clearance under submission number K980827, sponsored by Tucker & Associates. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-05-04.
- Submission: K980827
- Applicant / Sponsor: Tucker & Associates
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1998-05-04
Classification & Regulation
This clearance is catalogued under FDA product code LZB and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.