Clearance Summary
STERILE EXAMINATION GLOVE #5121-5126 received FDA 510(k) clearance under submission number K801998, sponsored by Pollak (Intl.), Ltd.. 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 1980-09-09.
- Submission: K801998
- Applicant / Sponsor: Pollak (Intl.), Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1980-09-09
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.