| Primary Device ID | 00810120952383 |
| NIH Device Record Key | c5474c22-bb11-4a03-885c-6e94690002d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVANCE IF 36 |
| Version Model Number | BPF-36XL |
| Company DUNS | 052262122 |
| Company Name | Diamond Gloves |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810120952369 [Unit of Use] |
| GS1 | 00810120952376 [Primary] |
| GS1 | 00810120952383 [Package] Contains: 00810120952376 Package: [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 | 2025-06-09 |
| Device Publish Date | 2025-05-30 |
| 00810120952413 | IF 36 Powder Free Nitrile Examination Gloves (Black), XX-LARGE |
| 00810120952383 | IF 36 Powder Free Nitrile Examination Gloves (Black), X-LARGE |
| 00810120952352 | IF 36 Powder Free Nitrile Examination Gloves (Black), LARGE |
| 00810120952321 | IF 36 Powder Free Nitrile Examination Gloves (Black), MEDIUM |
| 00810120952420 | IF 36 Powder Free Nitrile Examination Gloves (Black), SMALL |
| 00810120952260 | IF 36 Powder Free Nitrile Examination Gloves (Black), X-SMALL |