Clearance Summary
VINYL EXAM GLOVES, C&K STYLE #1025FS received FDA 510(k) clearance under submission number K891848, sponsored by C & K Mfg. & Sales Co.. 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 1989-05-12.
- Submission: K891848
- Applicant / Sponsor: C & K Mfg. & Sales Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-05-12
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.