DUKES

GUDID 09359332000495

DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size M (200 count)

Dukes International LLC

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

• Primary Device ID: 09359332000495
• NIH Device Record Key: 67d48e62-8b07-412a-a005-6fbb306abb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUKES
• Version Model Number: BIOFLEXX
• Company DUNS: 046648137
• Company Name: Dukes International LLC
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09359332000495 [Primary]
GS1	09359332000532 [Package]; Package: Carton [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: 2023-04-06
• Device Publish Date: 2023-03-29

On-Brand Devices [DUKES]

• 09359332000549: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size L (200 count)
• 09359332000525: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size S (200 count)
• 09359332000556: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size XL (200 count)
• 09359332000471: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size XL (100 count)
• 09359332000464: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size L (100 count)
• 09359332000457: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size M (100 count)
• 09359332000440: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size S (100 count)
• 09359332000495: DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size M (200 count)