The following data is part of a premarket notification filed by Dash Medical Gloves, Inc. with the FDA for Dash, Sullivan, Vital Gard.
| Device ID | K971044 |
| 510k Number | K971044 |
| Device Name: | DASH, SULLIVAN, VITAL GARD |
| Classification | Latex Patient Examination Glove |
| Applicant | DASH MEDICAL GLOVES, INC. 10180 SOUTH 54TH ST. Franklin, WI 53132 |
| Contact | Robert J Sullivan Jr. |
| Correspondent | Robert J Sullivan Jr. DASH MEDICAL GLOVES, INC. 10180 SOUTH 54TH ST. Franklin, WI 53132 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-21 |
| Decision Date | 1997-08-25 |