Clearance Summary
LATEX EXAM GLOVES, NON-STERILE received FDA 510(k) clearance under submission number K882583, sponsored by B Und J Instruments. 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 1988-07-14.
- Submission: K882583
- Applicant / Sponsor: B Und J Instruments
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1988-07-14
Classification & Regulation
This clearance is catalogued under FDA product code FMC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.