Hongxin

GUDID 06973073130230

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED), Model: L

SHANDONG HONGXIN CHEMICALS 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 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: 06973073130230
• NIH Device Record Key: 0ac01efe-4dfd-4aa7-b2eb-3126f059d013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hongxin
• Version Model Number: VINYL
• Company DUNS: 654249994
• Company Name: SHANDONG HONGXIN CHEMICALS 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973073130230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122828

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: 2022-09-13
• Device Publish Date: 2022-09-05

On-Brand Devices [Hongxin]

• 06973073130247: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED), Model: XL
• 06973073130230: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED), Model: L
• 06973073130209: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED), Model: M
• 06973073130148: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED), Model: S