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 |