ProMax Surgical Gown,

GUDID 00634916789256

ProMax Surgical Gown, MLR Front Yoke, 100% POLYESTER.

STANDARD TEXTILE CO., INC.

Surgical gown, reusable

• Primary Device ID: 00634916789256
• NIH Device Record Key: 55076b5b-cc3f-41e7-a522-61b145f4c5f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProMax Surgical Gown,
• Version Model Number: 75674764
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• 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: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916789256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921889

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

[00634916789256]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-19
• Device Publish Date: 2026-03-11

On-Brand Devices [ProMax Surgical Gown,]

• 00634916789263: ProMax Surgical Gown, MLR Front Yoke, 100% POLYESTER.
• 00634916789256: ProMax Surgical Gown, MLR Front Yoke, 100% POLYESTER.