GloveClub Nytrile X200 Nitrile Examination Gloves

GUDID 10369301004146

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

TOP QUALITY MANUFACTURING, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 10369301004146
• NIH Device Record Key: 99cab15e-d922-4ed1-bfd2-e4872ce44048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GloveClub Nytrile X200 Nitrile Examination Gloves
• Version Model Number: GC1125661
• Company DUNS: 113630649
• Company Name: TOP QUALITY MANUFACTURING, INC.
• Device Count: 180
• 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: 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

Customer Support Contacts

• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00369301004149 [Primary]
GS1	00369301004187 [Unit of Use]
GS1	10369301004146 [Package]; Contains: 00369301004149; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• LZA: Polymer patient examination glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-27
• Device Publish Date: 2026-02-19

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

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