The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nuzone Nitrile Surgical Gloves Powder Free.
| Device ID | K000179 |
| 510k Number | K000179 |
| Device Name: | NUZONE NITRILE SURGICAL GLOVES POWDER FREE |
| Classification | Surgeon's Gloves |
| Applicant | TERANG NUSA SDN BHD 1 JALAN 8, PENGKALAN CHEPA 2 INDUSTRIAL ZONE, Kota Bharu, Kelantan, MY 16100 |
| Contact | Chin-guan Low |
| Correspondent | Chin-guan Low TERANG NUSA SDN BHD 1 JALAN 8, PENGKALAN CHEPA 2 INDUSTRIAL ZONE, Kota Bharu, Kelantan, MY 16100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-20 |
| Decision Date | 2000-05-15 |