Primary Device ID | TQ26B83002 |
NIH Device Record Key | 4f778619-6030-495f-b694-2b113e6f201d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Smile 300 Blue Nitrile Examination Gloves |
Version Model Number | B8300 |
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 | TQ26B83000 [Unit of Use] |
HIBCC | TQ26B83001 [Primary] |
HIBCC | TQ26B83002 [Package] Contains: TQ26B83001 Package: [10 Units] In Commercial Distribution |
LZC | Medical Glove, Specialty |
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 |