Clearance Summary
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E received FDA 510(k) clearance under submission number K163041, sponsored by Pt. Medisafe Technologies. 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 2017-02-22.
- Submission: K163041
- Applicant / Sponsor: Pt. Medisafe Technologies
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2017-02-22
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.