Clearance Summary
STERILE VINYL EXAMINATION GLOVES, Powder Free received FDA 510(k) clearance under submission number K170612, sponsored by Primus Gloves Pvt Limited. 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 2017-10-23.
- Submission: K170612
- Applicant / Sponsor: Primus Gloves Pvt Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2017-10-23
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.