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 | K053442 |
| 510k Number | K053442 |
| 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 | 2005-12-09 |
| Decision Date | 2006-03-07 |