The following data is part of a premarket notification filed by Molnlycke Healthcare, Us Llc with the FDA for Biogel Orthopor Brown Surgical Glove.
| Device ID | K112089 |
| 510k Number | K112089 |
| Device Name: | BIOGEL ORTHOPOR BROWN SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTHCARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Angela L Bunn, Rac |
| Correspondent | Angela L Bunn, Rac MOLNLYCKE HEALTHCARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-21 |
| Decision Date | 2011-08-24 |
| Summary: | summary |