Clearance Summary
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE received FDA 510(k) clearance under submission number K030134, sponsored by Pt.Shamrock Manufacturing Corp.. 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 2003-03-25.
- Submission: K030134
- Applicant / Sponsor: Pt.Shamrock Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2003-03-25
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.