Clearance Summary
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE received FDA 510(k) clearance under submission number K990695, sponsored by Omnigrace (Thailand) , 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 1999-05-04.
- Submission: K990695
- Applicant / Sponsor: Omnigrace (Thailand) , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1999-05-04
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.