Clearance Summary
ELASTYREN - EXAMINATION AND DENTAL GLOVES received FDA 510(k) clearance under submission number K901394, sponsored by Danpren Gloves A/S. 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 1990-08-10.
- Submission: K901394
- Applicant / Sponsor: Danpren Gloves A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1990-08-10
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.