Clearance Summary
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE received FDA 510(k) clearance under submission number K051094, sponsored by Terang Nusa Sdn Bhd. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-06-06.
- Submission: K051094
- Applicant / Sponsor: Terang Nusa Sdn Bhd
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2005-06-06
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.