| Primary Device ID | B340790371M1 |
| NIH Device Record Key | 5b14b3e4-dad8-4098-9b5a-570f644f620a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 790371M |
| Catalog Number | 790371 |
| Company DUNS | 005052360 |
| Company Name | IMPACT PRODUCTS, LLC |
| Device Count | 1 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B340790371M1 [Primary] |
| 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 | 2020-07-06 |
| Device Publish Date | 2020-06-26 |
| 10729661269348 - Naturelle | 2024-02-09 Individually wrapped tampon |
| 10729661269447 - Naturelle | 2024-02-09 Individually wrapped tampon |
| 10729661269454 - Naturelle | 2024-02-09 Individually wrapped tampons |
| B340GREPLG1 - The Safety Zone | 2023-06-26 Large Latex Powder Free Exam Glove |
| B340GREPMD1 - The Safety Zone | 2023-06-26 Medium Latex Powder Free Exam Glove |
| B340GREPSM1 - THE SAFETY ZONE | 2023-06-26 Small Latex Powder Free Exam Glove |
| B340GREPXL1 - THE SAFETY ZONE | 2023-06-26 Small Latex Powder Free Exam Glove |
| B340790069L1 - NA | 2020-07-06 Large Exam Gloves Blue Nitrile |