The following data is part of a premarket notification filed by Lowenkamp Intl., Inc. with the FDA for Foxell Plus Multiple (personal Touch Tm).
| Device ID | K910439 |
| 510k Number | K910439 |
| Device Name: | FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM) |
| Classification | Latex Patient Examination Glove |
| Applicant | LOWENKAMP INTL., INC. P.O. BOX 878 Hazlehurst, MS 39083 |
| Contact | William Lowenkamp,jr |
| Correspondent | William Lowenkamp,jr LOWENKAMP INTL., INC. P.O. BOX 878 Hazlehurst, MS 39083 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-31 |
| Decision Date | 1991-02-25 |