The following data is part of a premarket notification filed by London Intl. Llc. with the FDA for Sterile, Powderfree Latex Examination Glove.
| Device ID | K980785 |
| 510k Number | K980785 |
| Device Name: | STERILE, POWDERFREE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 Dothan, AL 36304 |
| Contact | Neil Anderson |
| Correspondent | Neil Anderson LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 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 | 1998-03-02 |
| Decision Date | 1998-06-10 |