The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nugard Powderfree, Blue Polymer Coated Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Le.
| Device ID | K003545 |
| 510k Number | K003545 |
| Device Name: | NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2000-12-21 |