PureOrtho 1068501

GUDID D79010685013

PureOrtho Nitrile Powder-Free, X-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: D79010685013
• NIH Device Record Key: 8290422e-28ae-4358-ad8d-2cdb20ec1102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureOrtho
• Version Model Number: 1068501
• Catalog Number: 1068501
• 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
• 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
• 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
• 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
• 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	D79010685010 [Unit of Use]
HIBCC	D79010685011 [Primary]
HIBCC	D79010685013 [Package]; Contains: D79010685011; Package: Case [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170136

FDA Product Code

• LZC: Patient examination glove, specialty

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: 2022-11-24
• Device Publish Date: 2022-11-16

On-Brand Devices [PureOrtho]

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• D79010685033: PureOrtho Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Tiffany blue in color, Packag
• D79010685023: PureOrtho Nitrile Powder-Free, Small, Nitrile powder-free gloves, Tiffany blue in color, Packagi
• D79010685013: PureOrtho Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Tiffany blue in color, Packa