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 |