Clearance Summary
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves received FDA 510(k) clearance under submission number K160781, sponsored by Semperit Investments Asia Pte , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-05-02.
- Submission: K160781
- Applicant / Sponsor: Semperit Investments Asia Pte , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2017-05-02
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.