The following data is part of a premarket notification filed by Tillotson Rubber Co., Inc. with the FDA for Pilgrim Nitrile Latex Gloves (various Types).
| Device ID | K905765 |
| 510k Number | K905765 |
| Device Name: | PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES) |
| Classification | Latex Patient Examination Glove |
| Applicant | TILLOTSON RUBBER CO., INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Contact | Judith A Genzale |
| Correspondent | Judith A Genzale TILLOTSON RUBBER CO., INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-02-25 |