Clearance Summary
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K052728, sponsored by M/S. Kanam Latex Industries 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 2005-12-05.
- Submission: K052728
- Applicant / Sponsor: M/S. Kanam Latex Industries Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2005-12-05
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.