Clearance Summary
STERILE NITRILE SURGICAL GLOVES (POWDERED) received FDA 510(k) clearance under submission number K012479, sponsored by Smart Glove Corp. Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-09-26.
- Submission: K012479
- Applicant / Sponsor: Smart Glove Corp. Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2001-09-26
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.