The following data is part of a premarket notification filed by Hebei Hongsen Plastics Technology Co, Ltd with the FDA for Powder Free Nitrile Surgical Gloves, White Color (brand Name: Titanfine).
| Device ID | K140989 |
| 510k Number | K140989 |
| Device Name: | POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) |
| Classification | Surgeon's Gloves |
| Applicant | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD 853 DORCHESTER LN, UNITB New Milford, NJ 07646 |
| Contact | Charles Shen |
| Correspondent | Charles Shen HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD 853 DORCHESTER LN, UNITB New Milford, NJ 07646 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-17 |
| Decision Date | 2014-12-22 |
| Summary: | summary |