Smile 300 Blue Nitrile Examination Gloves

GUDID TQ26B83302

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size M

TOP QUALITY MANUFACTURING, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDTQ26B83302
NIH Device Record Key744fc67c-b9f2-4007-820f-e9f736b86ce1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmile 300 Blue Nitrile Examination Gloves
Version Model NumberB8330
Company DUNS113630649
Company NameTOP QUALITY MANUFACTURING, INC.
Device Count300
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)483-8559
Emailregulatory@topqualitygloves.com
Phone+1(800)483-8559
Emailregulatory@topqualitygloves.com
Phone+1(800)483-8559
Emailregulatory@topqualitygloves.com
Phone+1(800)483-8559
Emailregulatory@topqualitygloves.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCTQ26B83300 [Unit of Use]
HIBCCTQ26B83301 [Primary]
HIBCCTQ26B83302 [Package]
Contains: TQ26B83301
Package: [10 Units]
In Commercial Distribution

FDA Product Code

LZAPolymer patient examination glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-19
Device Publish Date2024-12-11

On-Brand Devices [Smile 300 Blue Nitrile Examination Gloves]

TQ26B83402Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size L
TQ26B83302Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size M
TQ26B83102Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size S
TQ26B83002Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size XS

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