The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Powder Free Polychloroprene Examination Glove Green.
| Device ID | K153510 |
| 510k Number | K153510 |
| Device Name: | Powder Free Polychloroprene Examination Glove Green |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-03-21 |