| Primary Device ID | 00841277108415 |
| NIH Device Record Key | 5ed0d5f5-3479-4044-bc4c-ce18ac61b006 |
| Commercial Distribution Discontinuation | 2024-11-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | green x-free |
| Version Model Number | SUNG201 |
| Catalog Number | SUNG201 |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 200 |
| 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 |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com | |
| Phone | 800-366-9545 |
| Glove.Info@SempermedUSA.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841277108361 [Primary] |
| GS1 | 00841277108415 [Unit of Use] |
| 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 | 2024-11-18 |
| Device Publish Date | 2024-11-08 |
| 00841277108590 | Nitrile Exam Glove PF, size XL |
| 00841277108583 | Nitrile Exam Glove PF, size L |
| 00841277108576 | Nitrile Exam Glove PF, size M |
| 00841277108569 | Nitrile Exam Glove, size S |
| 00841277108415 | Nitrile Exam Glove PF, size XS |