| Primary Device ID | 00841277100617 |
| NIH Device Record Key | a1081a0a-bc7a-4cf5-b7cb-43941762797e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarMed Ultra Nitrile Exam Glove |
| Version Model Number | SMTN254 |
| Catalog Number | SMTN254 |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 250 |
| 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 | 00841277100617 [Primary] |
| GS1 | 00841277103588 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-13 |
| Device Publish Date | 2020-01-01 |
| 00841277100679 | StarMed Ultra Nitrile Exam Glove, sample pack |
| 00841277100624 | StarMed Ultra Nitrile Exam Glove, size XL |
| 00841277100617 | StarMed Ultra Nitrile Exam Glove, size L |
| 00841277100600 | StarMed Ultra Nitrile Exam Glove, size M |
| 00841277100594 | StarMed Ultra Nitrile Exam Glove, size S |
| 00841277100570 | StarMed Ultra Nitrile Exam Glove, size XS |