| Primary Device ID | 00649531596127 |
| NIH Device Record Key | 13cca447-7e9d-4d09-8d5a-15f2571158a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLEX200™ |
| Version Model Number | FLEX200S |
| Company DUNS | 194914768 |
| Company Name | Dash Medical Gloves, Inc. |
| Device Count | 200 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00649531596028 [Primary] |
| GS1 | 00649531596127 [Package] Contains: 00649531596028 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 00649531596226 [Unit of Use] |
| 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 | 2023-10-16 |
| Device Publish Date | 2023-10-06 |
| 00649531596189 | Nitrile Exam Glove, Blue, XX-Large |
| 00649531596172 | Nitrile Exam Glove, Blue, X-Large |
| 00649531596165 | Nitrile Exam Glove, Blue, Large |
| 00649531596141 | Nitrile Exam Glove, Blue, Medium |
| 00649531596127 | Nitrile Exam Glove, Blue, Small |
| 00649531596110 | Nitrile Exam Glove, Blue, X-Small |