| Primary Device ID | 00080169153595 |
| NIH Device Record Key | 9f6ff37c-ce3a-4c0e-8ff1-6d51d5bfa0be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BORDOVA |
| Version Model Number | VINYL EXAM GLOVES SIZE LARGE |
| Company DUNS | 118764392 |
| Company Name | M.Y.T. USA Corp. |
| Device Count | 1 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00080169153595 [Primary] |
| LYZ | Vinyl 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 | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 00840169153588 | VINYL EXAM GLOVES |
| 00080169153595 | VINYL EXAM GLOVES |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BORDOVA 97513719 not registered Live/Pending |
BORDOVA INNOVATIONS INC 2022-07-21 |