The following data is part of a premarket notification filed by Ssl Americas, Inc. (regent Medical) with the FDA for Biogel Neotech Ii Powder-free Neoprene Surgeon's Glove.
| Device ID | K000421 |
| 510k Number | K000421 |
| Device Name: | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | SSL AMERICAS, INC. (REGENT MEDICAL) 3585 ENGINEERING DR. Norcross, GA 30092 -9214 |
| Contact | Bradley L Pugh |
| Correspondent | Bradley L Pugh SSL AMERICAS, INC. (REGENT MEDICAL) 3585 ENGINEERING DR. Norcross, GA 30092 -9214 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332551891916 | K000421 | 000 |
| 05060097937646 | K000421 | 000 |
| 05060097937738 | K000421 | 000 |
| 05060097937660 | K000421 | 000 |
| 05060097937752 | K000421 | 000 |
| 05060097937684 | K000421 | 000 |
| 05060097937776 | K000421 | 000 |
| 05060097937707 | K000421 | 000 |
| 07332551891428 | K000421 | 000 |
| 07332551891497 | K000421 | 000 |
| 07332551891565 | K000421 | 000 |
| 07332551891640 | K000421 | 000 |
| 07332551891701 | K000421 | 000 |
| 07332551891770 | K000421 | 000 |
| 07332551891855 | K000421 | 000 |
| 05060097937639 | K000421 | 000 |