| Primary Device ID | TQ26B83302 |
| NIH Device Record Key | 744fc67c-b9f2-4007-820f-e9f736b86ce1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smile 300 Blue Nitrile Examination Gloves |
| Version Model Number | B8330 |
| Company DUNS | 113630649 |
| Company Name | TOP QUALITY MANUFACTURING, INC. |
| Device Count | 300 |
| DM Exempt | true |
| 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 | true |
| 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 | false |
| Phone | +1(800)483-8559 |
| regulatory@topqualitygloves.com | |
| Phone | +1(800)483-8559 |
| regulatory@topqualitygloves.com | |
| Phone | +1(800)483-8559 |
| regulatory@topqualitygloves.com | |
| Phone | +1(800)483-8559 |
| regulatory@topqualitygloves.com |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | TQ26B83300 [Unit of Use] |
| HIBCC | TQ26B83301 [Primary] |
| HIBCC | TQ26B83302 [Package] Contains: TQ26B83301 Package: [10 Units] In Commercial Distribution |
| 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 | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| TQ26B83402 | Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size L |
| TQ26B83302 | Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size M |
| TQ26B83102 | Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size S |
| TQ26B83002 | Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size XS |