The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Biogel Ps Surgical Glove Series, Biogel Skinsense Surgical Glove Series.
| Device ID | K140477 |
| 510k Number | K140477 |
| Device Name: | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Curtis D Truesdale |
| Correspondent | Curtis D Truesdale MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-26 |
| Decision Date | 2015-03-23 |
| Summary: | summary |