PROMEDIX

GUDID 04897147760272

Heavy Duty 6 Mil-100 Pcs-M,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician

HONG KONG PROMEDIX COMPANY LIMITED

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 04897147760272
• NIH Device Record Key: 26eeabae-5071-472b-a62e-ce02b766573d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROMEDIX
• Version Model Number: PMD-HG6BLUE-M
• Company DUNS: 663245238
• Company Name: HONG KONG PROMEDIX COMPANY LIMITED
• 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	04897147760227 [Primary]
GS1	04897147760272 [Package]; Contains: 04897147760227; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123869

FDA Product Code

• LZA: Polymer 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: 2025-07-15
• Device Publish Date: 2025-07-07

On-Brand Devices [PROMEDIX]

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• 04897147760487: 4 Mil-100 Pcs-XL,Cobalt Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Clean
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• 04897147760456: 4 Mil-100 Pcs-S,Cobalt Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleani