PureOrthoSense 10684021068502

GUDID D790106840210685020

PureOrthoSense Nitrile Powder-Free, Small, Nitrile powder-free gloves, Tiffany blue in color, Packaging contains recycled material

PURELIFE, LLC

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

• Primary Device ID: D790106840210685020
• NIH Device Record Key: 5541d8f9-a776-4a53-beae-7c6dc4ad6954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureOrthoSense
• Version Model Number: 10684021068502
• Catalog Number: 10684021068502
• 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
• 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, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D790106840210685020 [Unit of Use]
HIBCC	D790106840210685021 [Primary]

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: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [PureOrthoSense]

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• D790106840410685040: PureOrthoSense Nitrile Powder-Free, Large, Nitrile powder-free gloves, Tiffany blue in color, Pa
• D790106840310685030: PureOrthoSense Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Tiffany blue in color, P
• D790106840210685020: PureOrthoSense Nitrile Powder-Free, Small, Nitrile powder-free gloves, Tiffany blue in color, Pa
• D790106840110685010: PureOrthoSense Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Tiffany blue in color,