PROMEDIX

GUDID 04897147760098

Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-XL,Black,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: 04897147760098
• NIH Device Record Key: 2efa6257-5c87-43b7-acbb-6ebeae264303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROMEDIX
• Version Model Number: PMD-HG5B-XL
• 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	04897147760098 [Primary]
GS1	04897147760142 [Package]; 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: 2025-07-04
• Device Publish Date: 2025-06-26

On-Brand Devices [PROMEDIX]

• 04897147760104: Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-XXL,Black,Disposable
• 04897147760098: Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-XL,Black,Disposable P
• 04897147760081: Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-L,Black,Disposable Po
• 04897147760074: Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-M,Black,Disposable Po
• 04897147760067: Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-S,Black,Disposable Po
• 04897147760050: Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-XXL,Black,Disposable Powder-Free Latex-F
• 04897147760043: Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-XL,Black,Disposable Powder-Free Latex-Fr
• 04897147760036: Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-L,Black,Disposable Powder-Free Latex-Fre
• 04897147760029: Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-M,Black,Disposable Powder-Free Latex-Fre
• 04897147760012: Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-S,Black,Disposable Powder-Free Latex-Fre
• 04897147760302: Heavy Duty 6 Mil-100 Pcs-XXL,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking,
• 04897147760296: Heavy Duty 6 Mil-100 Pcs-XL,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, C
• 04897147760289: Heavy Duty 6 Mil-100 Pcs-L,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cl
• 04897147760272: Heavy Duty 6 Mil-100 Pcs-M,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cl
• 04897147760265: Heavy Duty 6 Mil-100 Pcs-S,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cl