Clearance Summary
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX received FDA 510(k) clearance under submission number K031386, sponsored by Lalan Gloves (Pvt) , 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 2003-10-06.
- Submission: K031386
- Applicant / Sponsor: Lalan Gloves (Pvt) , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2003-10-06
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.