Clearance Summary
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K032549, sponsored by Matang Mfg. Sdn. Bhd.. 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 2003-09-08.
- Submission: K032549
- Applicant / Sponsor: Matang Mfg. Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2003-09-08
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.