The following data is part of a premarket notification filed by Tillotson Rubber Co., Inc. with the FDA for Powder Free, Non-sterile Examination Gloves.
Device ID | K903607 |
510k Number | K903607 |
Device Name: | POWDER FREE, NON-STERILE EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | TILLOTSON RUBBER CO., INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
Contact | Deborah Denitto |
Correspondent | Deborah Denitto 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 | 1990-08-07 |
Decision Date | 1990-08-17 |