| Primary Device ID | 00649531120117 |
| NIH Device Record Key | 71b67ba0-4fad-4c8d-bf92-75b0e0994306 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VitalGard® Latex |
| Version Model Number | VPF100XS |
| Company DUNS | 194914768 |
| Company Name | Dash Medical Gloves, Inc. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00649531020011 [Unit of Use] |
| GS1 | 00649531020110 [Primary] |
| GS1 | 00649531120117 [Package] Contains: 00649531020110 Package: Case [10 Units] In Commercial Distribution |
| LYY | Latex Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-30 |
| Device Publish Date | 2022-09-22 |
| 00649531120179 | Latex Exam Glove, X-Large |
| 00649531120162 | Latex Exam Glove, Large |
| 00649531120148 | Latex Exam Glove, Medium |
| 00649531120124 | Latex Exam Glove, Small |
| 00649531120117 | Latex Exam Glove, X-Small |