The following data is part of a premarket notification filed by London International Group, Inc. with the FDA for Skinsense Nitrile Powder-free Synthetic Medical Examination Glove.
| Device ID | K984249 |
| 510k Number | K984249 |
| Device Name: | SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan, AL 36304 |
| Contact | Neil Anderson |
| Correspondent | Neil Anderson LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan, AL 36304 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-30 |
| Decision Date | 1999-05-04 |