The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink.
| Device ID | K161932 |
| 510k Number | K161932 |
| Device Name: | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink |
| 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 | 2016-07-14 |
| Decision Date | 2016-11-28 |