GloveClub Nytrile X200 Nitrile Examination Gloves

GUDID 10369301004122

Nitrile Examination Gloves Not made with Natural Rubber Latex Color Green Size S

TOP QUALITY MANUFACTURING, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10369301004122
NIH Device Record Key109cf972-204a-4982-98f2-04d72080f9af
Commercial Distribution StatusIn Commercial Distribution
Brand NameGloveClub Nytrile X200 Nitrile Examination Gloves
Version Model NumberGC1125659
Company DUNS113630649
Company NameTOP QUALITY MANUFACTURING, INC.
Device Count200
DM Exemptfalse
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
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
Phone+1(800)483-8559
Emailregulatory@topqualitygloves.com
Phone+1(800)483-8559
Emailregulatory@topqualitygloves.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100369301004125 [Primary]
GS100369301004163 [Unit of Use]
GS110369301004122 [Package]
Contains: 00369301004125
Package: Case [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 Date2026-02-27
Device Publish Date2026-02-19

On-Brand Devices [GloveClub Nytrile X200 Nitrile Examination Gloves]

10369301004146Nitrile Examination Gloves Not made with Natural Rubber Latex Color Green Size L
10369301004139Nitrile Examination Gloves Not made with Natural Rubber Latex Color Green Size M
10369301004122Nitrile Examination Gloves Not made with Natural Rubber Latex Color Green Size S
10369301004115Nitrile Examination Gloves Not made with Natural Rubber Latex Color Green Size XS

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