| Primary Device ID | 00649531260172 |
| NIH Device Record Key | 25c7ee89-7634-4d6b-a2dc-b4485fa5fa54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Futura® |
| Version Model Number | FPH100XL |
| 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 | |
| Phone | 414-269-5298 |
| compliancedepartment@dashmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00649531060079 [Unit of Use] |
| GS1 | 00649531060178 [Primary] |
| GS1 | 00649531260172 [Package] Contains: 00649531060178 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 | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
| 00649531042228 - Black Maxx® Extreme Nitrile | 2025-09-17 Nitrile Exam Glove, Black, 7 mil, Small |
| 00649531042242 - Black Maxx® Extreme Nitrile | 2025-09-17 Nitrile Exam Glove, Black, 7 mil, Medium |
| 00649531042266 - Black Maxx® Extreme Nitrile | 2025-09-17 Nitrile Exam Glove, Black, 7 mil, Large |
| 00649531042273 - Black Maxx® Extreme Nitrile | 2025-09-17 Nitrile Exam Glove, Black, 7 mil, X-Large |
| 00649531042280 - Black Maxx® Extreme Nitrile | 2025-09-17 Nitrile Exam Glove, Black, 7 mil, XX-Large |
| 00649531202110 - Alasta® PRO | 2025-09-17 Nitrile Exam Glove, Blue, X-Small |
| 00649531202127 - Alasta® PRO | 2025-09-17 Nitrile Exam Glove, Blue, Small |
| 00649531202141 - Alasta® PRO | 2025-09-17 Nitrile Exam Glove, Blue, Medium |