J2-100 Advanced

GUDID 00850020592449

BLUE, NITRILE MEDICAL EXAMINATION GLOVES, LATEX-FREE, POWDER-FREE, NON-STERILE, AMBIDEXTROUS, CHEMO-RATED, ASTM D6978

J2 Medical Supply Inc.

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

• Primary Device ID: 00850020592449
• NIH Device Record Key: c8c51376-64fd-4e81-a08b-9439d763a8cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J2-100 Advanced
• Version Model Number: JVBBCHMDC
• Company DUNS: 117257038
• Company Name: J2 Medical Supply Inc.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com
• Phone: 855-615-8633
• Email: mariana.pisterman@j2medicalsupply.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850020592449 [Unit of Use]
GS1	00850020592562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170136

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: 2021-06-14
• Device Publish Date: 2021-06-04

On-Brand Devices [J2-100 Advanced]

• 00850020592456: BLUE, NITRILE MEDICAL EXAMINATION GLOVES, LATEX-FREE, POWDER-FREE, NON-STERILE, AMBIDEXTROUS, CH
• 00850020592449: BLUE, NITRILE MEDICAL EXAMINATION GLOVES, LATEX-FREE, POWDER-FREE, NON-STERILE, AMBIDEXTROUS, CH