The following data is part of a premarket notification filed by Lowenkamp Intl., Inc. with the FDA for Mala Latex Exam Gloves And Scan-sub.
| Device ID | K946154 |
| 510k Number | K946154 |
| Device Name: | MALA LATEX EXAM GLOVES AND SCAN-SUB |
| Classification | Latex Patient Examination Glove |
| Applicant | LOWENKAMP INTL., INC. 13022 MONTICELLO RD. P.O. BOX 878 Hazlehurst, MS 39083 |
| Contact | William Lowenkamp Jr. |
| Correspondent | William Lowenkamp Jr. LOWENKAMP INTL., INC. 13022 MONTICELLO RD. 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 | 1994-12-16 |
| Decision Date | 1995-01-11 |