| Primary Device ID | 00841277107180 |
| NIH Device Record Key | 83381616-5fa1-4298-a64c-75ea08d3acb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarMed Ultra/Tender Touch Nitrile Exam Glove |
| Version Model Number | SPK-035VB |
| Catalog Number | SPK-035VB |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 6 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00841277107173 [Primary] |
| GS1 | 00841277107180 [Unit of Use] |
| LZA | Polymer Patient Examination Glove |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-20 |
| Device Publish Date | 2023-03-10 |
| 00841277110012 - Sempermed Rose | 2025-03-25 Sempermed Rose Nitrile Exam Glove, size XS |
| 00841277110029 - Sempermed Rose | 2025-03-25 Sempermed Rose Nitrile Exam Glove, size S |
| 00841277110036 - Sempermed Rose | 2025-03-25 Sempermed Rose Nitrile Exam Glove, size M |
| 00841277110043 - Sempermed Rose | 2025-03-25 Sempermed Rose Nitrile Exam Glove, size L |
| 00841277110050 - Sempermed Rose | 2025-03-25 Sempermed Rose Nitrile Exam Glove, size XL |
| 00841277110067 - Sempermed Rose | 2025-03-25 Sempermed Rose Nitrile Exam Glove, sample pack |
| 00841277110135 - Sempermed skySense | 2025-03-25 Sempermed skySense, 300 Nitrile Exam Glove Powder Free- XS |
| 00841277110142 - Sempermed skySense | 2025-03-25 Sempermed skySense, 300 Nitrile Exam Glove Powder Free- S |