The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Synthetic Surgical Glove-powderfree Nuzone X2.
| Device ID | K041436 |
| 510k Number | K041436 |
| Device Name: | SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 |
| Classification | Surgeon's Gloves |
| Applicant | TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan, MY 16100 |
| Contact | Chin-guan Low |
| Correspondent | Chin-guan Low TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. 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 | 2004-05-28 |
| Decision Date | 2004-08-20 |
| Summary: | summary |