The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour.
| Device ID | K051562 |
| 510k Number | K051562 |
| Device Name: | NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR |
| 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 | 2005-06-13 |
| Decision Date | 2005-10-20 |
| Summary: | summary |