The following data is part of a premarket notification filed by Regent Medical Americas, Llc with the FDA for Biogel Latex Powder Free Sterile Surgeon's Glove.
| Device ID | K053441 |
| 510k Number | K053441 |
| Device Name: | BIOGEL LATEX POWDER FREE STERILE SURGEON'S 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 | 2006-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060097930999 | K053441 | 000 |
| 05060097931149 | K053441 | 000 |
| 05060097931132 | K053441 | 000 |
| 05060097930968 | K053441 | 000 |
| 05060097931118 | K053441 | 000 |
| 05060097931101 | K053441 | 000 |
| 05060097930937 | K053441 | 000 |
| 05060097930920 | K053441 | 000 |