The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nugard Nitril Nitrile Examination Glove.
| Device ID | K990841 |
| 510k Number | K990841 |
| Device Name: | NUGARD NITRIL NITRILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-05-17 |
| Summary: | summary |