PU YUAN

GUDID 06921825701481

Surgical protection in the operating room

Guangzhou Fuzelong Hygiene Material Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 06921825701481
• NIH Device Record Key: 47006ec6-52fe-45d0-ad1c-4982c7af1746
• Commercial Distribution Discontinuation: 2027-07-20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PU YUAN
• Version Model Number: SB2F-HoodGown-XL-EL-M-FP
• Company DUNS: 546983737
• Company Name: Guangzhou Fuzelong Hygiene Material 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06921825701481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222403

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: 2025-07-29
• Device Publish Date: 2025-07-21

On-Brand Devices [PU YUAN]

• 06921825700781: Anti-splash diaphragm
• 06921825701450: MC-0202L
• 06921825701481: Surgical protection in the operating room
• 06921825701474: Anti-splash diaphragm