Clearance Summary
DUBBLE BUTTERFLY PAT EXAM GLOVES/MFG: QUINGDAO FAC received FDA 510(k) clearance under submission number K893236, sponsored by China National Chemical Construction Corp.-Qingdao. 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 1989-08-15.
- Submission: K893236
- Applicant / Sponsor: China National Chemical Construction Corp.-Qingdao
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-08-15
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.