Clearance Summary
Latex Examination Gloves, Powder Free received FDA 510(k) clearance under submission number K213509, sponsored by Shandong Intco Medical Products Co, 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 2022-04-08.
- Submission: K213509
- Applicant / Sponsor: Shandong Intco Medical Products Co, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2022-04-08
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.