The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free With Protein Content Labeling Claim With 50ug/dm2 Or Less.
| Device ID | K151392 |
| 510k Number | K151392 |
| Device Name: | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free With Protein Content Labeling Claim With 50ug/dm2 Or Less |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-09-18 |