Clearance Summary
Palm Care Latex Examination Powder Free Gloves received FDA 510(k) clearance under submission number K202377, sponsored by Hi-Care Thai Gloves Co. , Ltd.. 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 2020-12-01.
- Submission: K202377
- Applicant / Sponsor: Hi-Care Thai Gloves Co. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2020-12-01
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.