Isolation Gown

GUDID 00634916790498

Isolation Gown, 3 Armhole, AAMI Level 1, Yellow, OSFA, Generic Polyester with Carbon, Wrap Around, Bound Around Neck and Armhole, Long Sleeves with Cuffs

STANDARD TEXTILE CO., INC.

Isolation gown, reusable

• Primary Device ID: 00634916790498
• NIH Device Record Key: 1288d0af-d225-421b-a77e-203bc0258b85
• Commercial Distribution Discontinuation: 2026-02-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Isolation Gown
• Version Model Number: 661Y4680
• 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: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916790498 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-06
• Device Publish Date: 2022-12-12

On-Brand Devices [Isolation Gown]

• 00634916796780: Isolation Gown, AAMI Level 2, Reusable, 100% Polyester, Tie Closures Neck and Waist, Raglan Slee
• 00634916790498: Isolation Gown, 3 Armhole, AAMI Level 1, Yellow, OSFA, Generic Polyester with Carbon, Wrap Aroun