Clearance Summary
Powder Free White, Black, and Purple Nitrile Examination Glove received FDA 510(k) clearance under submission number K231439, sponsored by S&S Glove Corporation. 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 2023-08-11.
- Submission: K231439
- Applicant / Sponsor: S&S Glove Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2023-08-11
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.