Clearance Summary
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG received FDA 510(k) clearance under submission number K031581, sponsored by Green Prospect Sdn Bhd. 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 2003-07-24.
- Submission: K031581
- Applicant / Sponsor: Green Prospect Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2003-07-24
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.