The following data is part of a premarket notification filed by Dash Medical Gloves Sdn Bhd with the FDA for Dash, Vital Gard.
| Device ID | K974114 |
| 510k Number | K974114 |
| Device Name: | DASH, VITAL GARD |
| Classification | Polymer Patient Examination Glove |
| Applicant | DASH MEDICAL GLOVES SDN BHD 10180 SOUTH 54TH ST. Franklin, WI 53132 |
| Contact | Robert J Sullivan |
| Correspondent | Robert J Sullivan DASH MEDICAL GLOVES SDN BHD 10180 SOUTH 54TH ST. Franklin, WI 53132 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1997-12-18 |