DOMREX™ Powder-Free Nitrile Exam Gloves

GUDID 10628032900036

Domrex Pharma Inc

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

• Primary Device ID: 10628032900036
• NIH Device Record Key: 9547497d-ba53-4fcb-829c-d9529395450c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMREX™ Powder-Free Nitrile Exam Gloves
• Version Model Number: M
• Company DUNS: 242411127
• Company Name: Domrex Pharma Inc
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628032900039 [Primary]
GS1	10628032900036 [Package]; Contains: 00628032900039; Package: Case [10 Units]; In Commercial Distribution

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: 2024-01-29
• Device Publish Date: 2024-01-19

On-Brand Devices [DOMREX™ Powder-Free Nitrile Exam Gloves]

• 10628032900050: XL
• 10628032900043: L
• 10628032900036: M
• 10628032900029: S
• 00628032900015: XS