The following data is part of a premarket notification filed by Terang Nusa Snd Bhd with the FDA for Nuzone X2g Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested For Use With Chemotherapy Drugs.
| Device ID | K150973 |
| 510k Number | K150973 |
| Device Name: | NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | TERANG NUSA SND BHD 1 JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, MY 16100 |
| Contact | Robert Hill |
| Correspondent | Robert Hill TERANG NUSA SND BHD 1 JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, MY 16100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-13 |
| Decision Date | 2015-08-04 |