The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Ansell Denta Gloves.
| Device ID | K895660 |
| 510k Number | K895660 |
| Device Name: | ANSELL DENTA GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand, TH |
| Contact | John Moushall |
| Correspondent | John Moushall ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1990-01-02 |