The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Sensi Grip Latex Examination Glove, Powdered Contains 200 Mcgm Or Less Of Total Water Extractable Protein Per Gram.
| Device ID | K000745 |
| 510k Number | K000745 |
| Device Name: | SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
| Classification | Latex Patient Examination Glove |
| Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 -5030 |
| Contact | Thomas N Tillotson |
| Correspondent | Thomas N Tillotson TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 -5030 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-08 |
| Decision Date | 2000-05-03 |