Clearance Summary
ATTENUATING SURGICAL GLOVE received FDA 510(k) clearance under submission number K891315, sponsored by F & L Medical Products 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 1989-10-05.
- Submission: K891315
- Applicant / Sponsor: F & L Medical Products Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-10-05
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.