PureSense 1068405

GUDID D79010684053

PureSense Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material

PURELIFE, LLC

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

• Primary Device ID: D79010684053
• NIH Device Record Key: 7de8924a-4e38-4351-9ed5-81b2c1cb104f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureSense
• Version Model Number: 1068405
• Catalog Number: 1068405
• Company DUNS: 828690904
• Company Name: PURELIFE, LLC
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79010684050 [Unit of Use]
HIBCC	D79010684051 [Primary]
HIBCC	D79010684053 [Package]; Contains: D79010684051; Package: Case [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212182

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [PureSense]

• D79010684053: PureSense Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Pink in color, Packaging con
• D79010684043: PureSense Nitrile Powder-Free, Large, Nitrile powder-free gloves, Pink in color, Packaging conta
• D79010684033: PureSense Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Pink in color, Packaging cont
• D79010684023: PureSense Nitrile Powder-Free, Small, Nitrile powder-free gloves, Pink in color, Packaging conta
• D79010684013: PureSense Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Pink in color, Packaging con