Clearance Summary
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance under submission number K183441, 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 2019-10-04.
- Submission: K183441
- 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: 2019-10-04
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.