The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for True Advantage Non-sterile Powder Free Purple Nitrile Examination Glove.
Device ID | K013016 |
510k Number | K013016 |
Device Name: | TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE |
Classification | Polymer Patient Examination Glove |
Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
Contact | F. W Perrella |
Correspondent | F. W Perrella TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-07 |
Decision Date | 2001-10-19 |
Summary: | summary |