Clearance Summary
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M received FDA 510(k) clearance under submission number K133953, sponsored by Hartalega 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 2014-05-28.
- Submission: K133953
- Applicant / Sponsor: Hartalega Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2014-05-28
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.