The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Pure Advantage Powder Free Nitrile Hypoallergenic Surgical Glove.
| Device ID | K971945 |
| 510k Number | K971945 |
| Device Name: | PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
| Contact | Edward Markovic |
| Correspondent | Edward Markovic TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-07-14 |
| Summary: | summary |