Clearance Summary
Sterile Latex Surgical Gloves Powder Free received FDA 510(k) clearance under submission number K211478, sponsored by Aspen Glove Sdn. Bhd.. 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 2021-09-16.
- Submission: K211478
- Applicant / Sponsor: Aspen Glove Sdn. Bhd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2021-09-16
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.