PureSkin 1020102

GUDID D79010201020

PureSkin Latex Powder-Free, Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material

PURELIFE, LLC

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: D79010201020
• NIH Device Record Key: 34bdbcac-0fe0-441f-a2ab-1e22ec2096cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureSkin
• Version Model Number: 1020102
• Catalog Number: 1020102
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79010201020 [Unit of Use]
HIBCC	D79010201021 [Primary]

FDA Product Code

• LYY: Latex 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: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [PureSkin]

• D79010201050: PureSkin Latex Powder-Free, X-Large, Fully-textured, Polymer-coated, Packaging contains at least
• D79010201040: PureSkin Latex Powder-Free, Large, Fully-textured, Polymer-coated, Packaging contains at least 7
• D79010201030: PureSkin Latex Powder-Free, Medium, Fully-textured, Polymer-coated, Packaging contains at least
• D79010201020: PureSkin Latex Powder-Free, Small, Fully-textured, Polymer-coated, Packaging contains at least 7
• D79010201010: PureSkin Latex Powder-Free, X-Small, Fully-textured, Polymer-coated, Packaging contains at least