Huayuan

GUDID 06973082350704

vinyl, Blue, XL

Jiangsu Huayuan Medical Technology Co., Ltd.

Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 06973082350704
• NIH Device Record Key: 08ba322f-9f79-42e5-83d7-24d9af4c4ed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huayuan
• Version Model Number: XL
• Company DUNS: 560456236
• Company Name: Jiangsu Huayuan Medical Technology 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973082350704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211045

FDA Product Code

• LYZ: Vinyl Patient Examination Glove

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-28
• Device Publish Date: 2022-03-19

On-Brand Devices [Huayuan]

• 06973082350704: vinyl, Blue, XL
• 06973082350698: vinyl, Blue, L
• 06973082350681: vinyl, Blue, M
• 06973082350674: vinyl, Blue, S
• 06973082350667: vinyl, Blue, XS
• 06973082350056: vinyl, clear, XS
• 06973082350049: vinyl, clear, XL
• 06973082350032: vinyl, clear, L
• 06973082350025: vinyl, clear, M
• 06973082350018: vinyl, clear, S