Clearance Summary
Hi Coat Powder Free Latex Patient Examination Gloves received FDA 510(k) clearance under submission number K972539, sponsored by P.T. Latexindo Tobaperkasa. 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 1997-11-18.
- Submission: K972539
- Applicant / Sponsor: P.T. Latexindo Tobaperkasa
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1997-11-18
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.