Clearance Summary
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs received FDA 510(k) clearance under submission number K171378, sponsored by Semperit Investments Asia Pte , Ltd.. 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 2017-09-14.
- Submission: K171378
- Applicant / Sponsor: Semperit Investments Asia Pte , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2017-09-14
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.