The following data is part of a premarket notification filed by Hutchinson Sante S.n.c. with the FDA for G-derm Powder-free Synthetic Surgical Glove.
| Device ID | K121335 |
| 510k Number | K121335 |
| Device Name: | G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | HUTCHINSON SANTE S.N.C. RUE MARRET PATUREL Liancourt, FR F-60140 |
| Contact | Raffi Krikorian |
| Correspondent | Raffi Krikorian HUTCHINSON SANTE S.N.C. RUE MARRET PATUREL Liancourt, FR F-60140 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-03 |
| Decision Date | 2012-09-13 |
| Summary: | summary |