Clearance Summary
Stronghold Group Nitrile Examination Glove, Powder Free received FDA 510(k) clearance under submission number K213859, sponsored by Stronghold Group, LLC. 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 2022-01-13.
- Submission: K213859
- Applicant / Sponsor: Stronghold Group, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2022-01-13
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.