Tronex International, Inc.

GUDID 00097604945400

Gown, Isolation, Multilayer, AAMI Level 3, Tape-Tab Neck , Elastic Cuffs, Fluid Resistant, Latex-Free, Yellow, 2X Large

TRONEX INTERNATIONAL, INC.

Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use

• Primary Device ID: 00097604945400
• NIH Device Record Key: 6e6de1c6-3836-40d0-9d50-f2ea3290e8f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tronex International, Inc.
• Version Model Number: MLN94540Y
• Company DUNS: 615425519
• Company Name: TRONEX INTERNATIONAL, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: false

Customer Support Contacts

• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com
• Phone: 973-335-2888
• Email: tronexproductmanagement@tronexcompany.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00097604945400 [Unit of Use]
GS1	10097604945407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171535

FDA Product Code

• FYC: Gown, Isolation, Surgical

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: 2023-04-18
• Device Publish Date: 2023-04-10

On-Brand Devices [Tronex International, Inc.]

• 10097604925843: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604925836: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604925829: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604925812: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604924648: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604924631: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604924624: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604924617: Glove, Exam, Nitrile, Sterile, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free
• 10097604917749: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Extra-Large
• 10097604917732: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Large
• 10097604917725: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Medium
• 10097604917718: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Pair, Blue, Small
• 10097604913345: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Extra-Large
• 10097604913338: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Large
• 10097604913321: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Medium
• 10097604913314: Glove, Exam, Nitrile, Sterile, Fully Textured, Powder-Free, Latex-Free Single, Blue, Small
• 00097604983051: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
• 00097604983044: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
• 00097604983037: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
• 00097604983020: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
• 00097604983013: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
• 00097604983006: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Bl
• 00097604977050: Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
• 00097604977043: Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
• 00097604977036: Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
• 00097604977029: Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
• 00097604977012: Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
• 00097604977005: Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free,
• 00097604967242: Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Extra-Large
• 00097604967235: Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Large
• 00097604967228: Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Medium
• 00097604967211: Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Small
• 00097604967204: Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Pink, Extra-Small
• 00097604966252: Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
• 00097604966245: Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
• 00097604966238: Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
• 00097604966221: Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
• 00097604966214: Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
• 00097604966207: Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-F
• 00097604939447: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
• 00097604939430: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Lar
• 00097604939423: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Med
• 00097604939416: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Sma
• 00097604939409: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
• 00097604939348: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
• 00097604939331: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Lar
• 00097604939324: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Med
• 00097604939317: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Sma
• 00097604939300: Glove, Exam, Nitrile, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Blue, Ext
• 00097604925259: Glove, Exam, Nitrile, Fingertip-Textured, Powder-Free, Latex-Free, Blue, 2X-Large