Clearance Summary
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE received FDA 510(k) clearance under submission number K072614, 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 2008-04-15.
- Submission: K072614
- 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: 2008-04-15
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.