Clearance Summary
PATIENT EXAMIN GLOVES(MFG: SHANGHAI FACTORY) received FDA 510(k) clearance under submission number K894090, sponsored by Everbest Machinery (U.S.A.) Co. , 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 1990-04-16.
- Submission: K894090
- Applicant / Sponsor: Everbest Machinery (U.S.A.) Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1990-04-16
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.