Clearance Summary
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 received FDA 510(k) clearance under submission number K041436, sponsored by Terang Nusa 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 2004-08-20.
- Submission: K041436
- Applicant / Sponsor: Terang Nusa Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2004-08-20
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.