| Primary Device ID | 00649531042266 |
| NIH Device Record Key | fbc6358b-eaa5-42e4-b9ba-3d5289ae8b7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Black Maxx® Extreme Nitrile |
| Version Model Number | BMNE100L |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00649531042068 [Unit of Use] |
| GS1 | 00649531042167 [Primary] |
| GS1 | 00649531042266 [Package] Contains: 00649531042167 Package: Case [10 Units] In Commercial Distribution |
| LZA | Polymer 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 | 2025-09-17 |
| Device Publish Date | 2025-09-09 |
| 00649531042280 | Nitrile Exam Glove, Black, 7 mil, XX-Large |
| 00649531042273 | Nitrile Exam Glove, Black, 7 mil, X-Large |
| 00649531042266 | Nitrile Exam Glove, Black, 7 mil, Large |
| 00649531042242 | Nitrile Exam Glove, Black, 7 mil, Medium |
| 00649531042228 | Nitrile Exam Glove, Black, 7 mil, Small |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BLACK MAXX 85500799 4186580 Dead/Cancelled |
H & S Performance, LLC 2011-12-21 |
![]() BLACK MAXX 85377814 not registered Dead/Abandoned |
H&S Performance 2011-07-21 |
![]() BLACK MAXX 85320614 4087006 Live/Registered |
DASH MEDICAL GLOVES, INC. 2011-05-13 |
![]() BLACK MAXX 76144478 2817805 Dead/Cancelled |
KEE Actions Sports II LLC 2000-10-10 |
![]() BLACK MAXX 75168146 2237966 Live/Registered |
CARTON CRAFT SUPPLY, INC. 1996-09-18 |