ProWorks GL-N115FX

GUDID 10075289222853

ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 3 mil, X-Large, 100/bx, 10 bxs/cs

TRANZONIC ACQUISITION CORP.

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

• Primary Device ID: 10075289222853
• NIH Device Record Key: f79ef0a7-6f46-444c-b48f-0dfd3d996f5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProWorks
• Version Model Number: GL-N115FX
• Catalog Number: GL-N115FX
• Company DUNS: 090125555
• Company Name: TRANZONIC ACQUISITION CORP.
• Device Count: 100
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com
• Phone: 8003219832
• Email: info@hospeco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075289222856 [Primary]
GS1	10075289222853 [Package]; Contains: 00075289222856; Package: box [10 Units]; In Commercial Distribution
GS1	70075289222855 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151528

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: 2020-04-28
• Device Publish Date: 2020-04-20

On-Brand Devices [ProWorks]

• 10075289222853: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 3 mil, X-Large, 100/bx, 10
• 10075289222846: ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Large, 100/bx, 10 bxs/cs
• 10075289222839: ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Medium, 100/bx, 10 bxs/cs
• 10075289222822: ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Small, 100/bx, 10 bxs/cs
• 10075289222266: ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, XX-Larg
• 10075289222259: ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, X-Large
• 10075289222242: ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, Large,
• 10075289222235: ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, Medium,
• 10075289222228: ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, Small,
• 10075289145145: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 4 mil, X-Large, 100/bx, 10 b
• 10075289145138: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 4 mil, Large, 100/bx, 10 bxs
• 10075289145121: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 4 mil, Medium, 100/bx, 10 bx
• 10075289145114: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 4 mil, Small, 100/bx, 10 bxs
• 10075289130349: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, X-Large, 100/b
• 10075289130332: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, Large, 100/bx,
• 10075289130325: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, Medium, 100/bx
• 10075289130318: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, Small, 100/bx,
• 10075289130301: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, X-Small, 100/b
• 10075289127363: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 8 mil, XX-Large, 50/bx, 10
• 10075289127356: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 8 mil, X-Large, 50/bx, 10 b
• 10075289127349: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 8 mil, Large, 50/bx, 10 bxs
• 10075289127332: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 8 mil, Medium, 50/bx, 10 bx
• 10075289127325: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 8 mil, Small, 50/bx, 10 bxs
• 10075289125055: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, X-Small, 200/b
• 10075289125048: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, X-Large, 200/b
• 10075289125031: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, Large, 200/bx,
• 10075289125024: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, Medium, 200/bx
• 10075289125017: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue-Violet, 3 mil, Small, 200/bx,
• 10075289222211: ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, XSmall,
• 10075289103039: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 3 mil, XLarge, 100/bx, 10 bx
• 10075289103022: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 3 mil, Large, 100/bx, 10 bxs
• 10075289103015: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 3 mil, Medium, 100/bx, 10 bx
• 10075289103008: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 3 mil, Small, 100/bx, 10 bxs