Reversible Isolation Gown

GUDID 00634916881356

Reversible Isolation Gown w/ Raglan Sleeves,99% POLYESTER, 1%.

STANDARD TEXTILE CO., INC.

Isolation gown, reusable

• Primary Device ID: 00634916881356
• NIH Device Record Key: 8e60dee5-1f72-4e39-bc46-5401357aee8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reversible Isolation Gown
• Version Model Number: 661Y5741
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: 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	00634916881356 [Primary]

FDA Product Code

• OEA: Non-Surgical Gown

Sterilization

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

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

Moist Heat or Steam Sterilization

[00634916881356]

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 [Reversible Isolation Gown]

• 00634916881363: Reversible Isolation Gown, Raglan Sleeves, 99% POLYESTER, 1% CARBON .
• 00634916881356: Reversible Isolation Gown w/ Raglan Sleeves,99% POLYESTER, 1%.