The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Skinsense Polyisoprene Underglove.
| Device ID | K081180 |
| 510k Number | K081180 |
| Device Name: | SKINSENSE POLYISOPRENE UNDERGLOVE |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley 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 | 2008-04-25 |
| Decision Date | 2008-08-26 |
| Summary: | summary |