The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nugard Nitile Grey Color.
| Device ID | K102230 |
| 510k Number | K102230 |
| Device Name: | NUGARD NITILE GREY COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan, MY 16100 |
| Contact | Robert Hill |
| Correspondent | Robert Hill TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan, MY 16100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2010-09-10 |