| Primary Device ID | 00649531434078 |
| NIH Device Record Key | 7a923e82-eb68-4934-a587-ac5825147cdd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nitrile PF |
| Version Model Number | NPF100XL |
| 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 | |
| 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 | 00649531310075 [Unit of Use] |
| GS1 | 00649531310679 [Primary] |
| GS1 | 00649531434078 [Package] Contains: 00649531310679 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 | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
| 00649531434078 | Nitrile Exam Glove, Pearlescent Blue, X-Large |
| 00649531434061 | Nitrile Exam Glove, Pearlescent Blue, Large |