| Primary Device ID | 30744514008862 |
| NIH Device Record Key | 464a110d-a75f-4aac-874e-2044444b0944 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HandPlus Nitrile XT8 |
| Version Model Number | 088-6 |
| Company DUNS | 782209340 |
| Company Name | Uniseal |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10744514008868 [Unit of Use] |
| GS1 | 20744514008865 [Primary] |
| GS1 | 30744514008862 [Package] Contains: 20744514008865 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 | 2022-08-30 |
| Device Publish Date | 2022-08-22 |
| 10744514008899 | Nitrile Powder Free Diamond Textured Orange Exam Gloves, Non- Sterile, size XL |
| 10744514008882 | Nitrile Powder Free Diamond Textured Orange Exam Gloves, Non- Sterile, size L |
| 10744514008875 | Nitrile Powder Free Diamond Textured Orange Exam Gloves, Non- Sterile, size M |
| 30744514008862 | Nitrile Powder Free Diamond Textured Orange Exam Gloves, Non- Sterile, size S |
| 10744514008806 | Nitrile Powder Free Diamond Textured Orange Exam Gloves, Non- Sterile, size XXL |