The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms Or Less Of Water Extractable Protein.
| Device ID | K170779 |
| 510k Number | K170779 |
| Device Name: | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms Or Less Of Water Extractable Protein |
| Classification | Latex Patient Examination Glove |
| Applicant | Terang Nusa Sdn Bhd 1 Jalan 8, Pengkalan Chepa 2, Industrial Zone Kota Bharu, MY 16100 |
| Contact | Robert Hill |
| Correspondent | Robert Hill Terang Nusa Sdn Bhd 1 Jalan 8, Pengkalan Chepa 2, Industrial Zone Kota Bharu, MY 16100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-15 |
| Decision Date | 2017-05-24 |