The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Biogel Pi Orthopro Brown Surgical Glove.
| Device ID | K112257 |
| 510k Number | K112257 |
| Device Name: | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Angela L Bunn |
| Correspondent | Angela L Bunn 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-05 |
| Decision Date | 2011-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332551976408 | K112257 | 000 |
| 07332551976330 | K112257 | 000 |
| 07332551976125 | K112257 | 000 |
| 07332551976064 | K112257 | 000 |
| 07332551975920 | K112257 | 000 |
| 07332551976279 | K112257 | 000 |
| 07332551975999 | K112257 | 000 |