Reinforced Sterile Level 4 Surgical Gown

GUDID 06973384924115

Hubei Xinxin Non-woven Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 06973384924115
• NIH Device Record Key: 81569666-4383-4dda-8d56-bf8eef99f07b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reinforced Sterile Level 4 Surgical Gown
• Version Model Number: GM4025
• Company DUNS: 544358965
• Company Name: Hubei Xinxin Non-woven Co., Ltd.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973384924115 [Primary]

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-09
• Device Publish Date: 2025-09-01

Devices Manufactured by Hubei Xinxin Non-woven Co., Ltd.

• 06973384924115 - Reinforced Sterile Level 4 Surgical Gown: 2025-09-09
• 06973384924115 - Reinforced Sterile Level 4 Surgical Gown: 2025-09-09
• 06973384924078 - Sterile Level 3 Surgical Gown: 2024-12-06