Clearance Summary
BLACK NITRILE EXAMINATION GLOVES received FDA 510(k) clearance under submission number K083908, sponsored by Innovative Gloves 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 2009-03-06.
- Submission: K083908
- Applicant / Sponsor: Innovative Gloves Co;, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2009-03-06
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.