Clearance Summary
BIOSHIELD AND UNIVERSAL LATEX EXAM GLOVES received FDA 510(k) clearance under submission number K891268, sponsored by Dah Lee Rubber Industries (Thai) , 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 1989-08-22.
- Submission: K891268
- Applicant / Sponsor: Dah Lee Rubber Industries (Thai) , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-08-22
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.