Clearance Summary
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM received FDA 510(k) clearance under submission number K102189, sponsored by Latexx Manufacturing 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 2012-03-14.
- Submission: K102189
- Applicant / Sponsor: Latexx Manufacturing Sdn.Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2012-03-14
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.