Clearance Summary
L3 (LEAD LATEX LYSNIG GLOVES) received FDA 510(k) clearance under submission number K882437, sponsored by The Branford Co.. 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 1989-05-11.
- Submission: K882437
- Applicant / Sponsor: The Branford Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-05-11
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.