The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Pure Advantage Nitrile Hypoallergenic Patient Examination Gloves.
| Device ID | K954574 |
| 510k Number | K954574 |
| Device Name: | PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
| Contact | Imogene Tibbetts |
| Correspondent | Imogene Tibbetts 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 | 1995-10-02 |
| Decision Date | 1995-12-21 |