The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Sensiflex Plus Sterile Latex Surgical Glove Powderfree With Protein Content Labeling Claim.
| Device ID | K140355 |
| 510k Number | K140355 |
| Device Name: | SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM |
| Classification | Surgeon's Gloves |
| Applicant | TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan, MY 16100 |
| Contact | Robert Hill |
| Correspondent | Robert Hill TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan, 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 | 2014-02-12 |
| Decision Date | 2014-11-06 |