| Primary Device ID | 00841277105629 |
| NIH Device Record Key | 0cf5552f-f7d7-4500-8318-492733ee85b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SemperShield EC Nitrile Exam Glove |
| Version Model Number | SSEC104 |
| Catalog Number | SSEC104 |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 50 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841277105568 [Primary] |
| GS1 | 00841277105629 [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 | 2020-03-09 |
| Device Publish Date | 2020-03-01 |
| 00841277105599 | SemperShield EC Nitrile Exam Glove, sample pack |
| 00841277105636 | SemperShield EC Nitrile Exam Glove, size XL |
| 00841277105629 | SemperShield EC Nitrile Exam Glove, size L |
| 00841277105612 | SemperShield EC Nitrile Exam Glove, size M |
| 00841277105605 | SemperShield EC Nitrile Exam Glove, size S |
| 00841277107128 | SemperShield EC Nitrile Exam Glove, size XL |
| 00841277107111 | SemperShield EC Nitrile Exam Glove, size L |
| 00841277107104 | SemperShield EC Nitrile Exam Glove, size M |
| 00841277107098 | SemperShield EC Nitrile Exam Glove, size S |