Disposable Surgical Gowns

GUDID 06938024400138

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 06938024400138
• NIH Device Record Key: 1adc5852-1b59-40b1-b49a-52aca57f6ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Surgical Gowns
• Version Model Number: SUM201022-L
• Company DUNS: 421260215
• Company Name: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938024400138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120192

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-09

On-Brand Devices [Disposable Surgical Gowns]

• 06938024400121: XL
• 06938024400138: SUM201022-L