Clearance Summary
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) received FDA 510(k) clearance under submission number K211758, sponsored by Hartalega NGC Sdn. Bhd.. 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 2021-08-03.
- Submission: K211758
- Applicant / Sponsor: Hartalega NGC Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-08-03
Classification & Regulation
This clearance is catalogued under FDA product code OPC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.