The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Sensiflex Powderfree Latex Examination Glove.
| Device ID | K990488 |
| 510k Number | K990488 |
| Device Name: | SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | TERANG NUSA SDN BHD LOT E4(4), JALAN 8 PENGKALAN CHEPA II FTZ Kota Bharu, Kelantan, MY 16100 |
| Contact | Chin Guan Low |
| Correspondent | Chin Guan Low TERANG NUSA SDN BHD LOT E4(4), JALAN 8 PENGKALAN CHEPA II FTZ Kota Bharu, Kelantan, MY 16100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-16 |
| Decision Date | 1999-05-28 |
| Summary: | summary |