| Primary Device ID | 00850043630463 |
| NIH Device Record Key | 14805e15-cfbe-4d75-b7a8-35f99c851db1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIAMOND GLOVES- X ADVANCE IF80 |
| Version Model Number | NE80M |
| Company DUNS | 052262122 |
| Company Name | Diamond Gloves |
| Device Count | 50 |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850043630463 [Package] Contains: 00850043630524 Package: [10 Units] In Commercial Distribution |
| GS1 | 00850043630470 [Unit of Use] |
| GS1 | 00850043630524 [Primary] |
| 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 | 2022-11-21 |
| Device Publish Date | 2022-11-11 |
| 00850043630791 | IF80 11" High Risk Powder Free Textured Nitrile Examination Gloves, EXTRA-LARGE |
| 00850043630494 | IF80 11" High Risk Powder Free Textured Nitrile Examination Gloves, XX-LARGE |
| 00850043630999 | IF80 11" High Risk Powder Free Textured Nitrile Examination Gloves, LARGE |
| 00850043630463 | IF80 11" High Risk Powder Free Textured Nitrile Examination Gloves, MEDIUM |
| 00850043630500 | IF80 11" High Risk Powder Free Textured Nitrile Examination Gloves, SMALL |