Clearance Summary
AspenMed+ received FDA 510(k) clearance under submission number K213076, sponsored by Aspen Glove Sdn. Bhd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-12-20.
- Submission: K213076
- Applicant / Sponsor: Aspen Glove Sdn. Bhd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.