The following data is part of a premarket notification filed by Regent Medical Americas, Llc with the FDA for Biogel Skinsense Poly-isoprene Powder-free Non-latex Glove.
| Device ID | K050184 |
| 510k Number | K050184 |
| Device Name: | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | REGENT MEDICAL AMERICAS, LLC 3585 ENGINEERING DR, STE 250 Norcross, GA 30092 |
| Contact | Kathleen Harris |
| Correspondent | Kathleen Harris REGENT MEDICAL AMERICAS, LLC 3585 ENGINEERING DR, STE 250 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 | 2005-01-27 |
| Decision Date | 2005-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332551976903 | K050184 | 000 |
| 07332551889654 | K050184 | 000 |
| 07332551889579 | K050184 | 000 |
| 07332551889449 | K050184 | 000 |
| 07332551889364 | K050184 | 000 |
| 07332551184926 | K050184 | 000 |
| 07332551184865 | K050184 | 000 |
| 07332551184810 | K050184 | 000 |
| 07332551184766 | K050184 | 000 |
| 07332551184711 | K050184 | 000 |
| 07332551184674 | K050184 | 000 |
| 07332551184612 | K050184 | 000 |
| 07332551184575 | K050184 | 000 |
| 07332551892319 | K050184 | 000 |
| 07332551889715 | K050184 | 000 |
| 07332551889784 | K050184 | 000 |
| 07332551889869 | K050184 | 000 |
| 07332551976828 | K050184 | 000 |
| 07332551976750 | K050184 | 000 |
| 07332551976682 | K050184 | 000 |
| 07332551976613 | K050184 | 000 |
| 07332551976545 | K050184 | 000 |
| 07332551976477 | K050184 | 000 |
| 07332551892517 | K050184 | 000 |
| 07332551892449 | K050184 | 000 |
| 07332551892371 | K050184 | 000 |
| 07332551892234 | K050184 | 000 |
| 07332551892173 | K050184 | 000 |
| 07332551892104 | K050184 | 000 |
| 07332551892012 | K050184 | 000 |
| 07332551889500 | K050184 | 000 |