The following data is part of a premarket notification filed by London International Group, Inc. with the FDA for Regent Skindende Exam Glove, Regent Biogel D, Regentbiogel Diagnostic (powderfree).
| Device ID | K991677 |
| 510k Number | K991677 |
| Device Name: | REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan, AL 36304 |
| Contact | Bradley L Pugh |
| Correspondent | Bradley L Pugh LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan, AL 36304 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 2000-04-12 |