NitriTech

GUDID 10850018374689

4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Finish, Powder Free, Beaded Cuff, Blue, Size X-Large

SUMMIT GLOVE INC.

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 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: 10850018374689
• NIH Device Record Key: 94ef5326-f815-414b-ac30-4ba0e890e7b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NitriTech
• Version Model Number: 76750PF-XL
• Company DUNS: 054386458
• Company Name: SUMMIT GLOVE 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com
• Phone: +1(330)868-0066
• Email: klynn@summitglove.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018374682 [Primary]
GS1	00850018374699 [Unit of Use]
GS1	10850018374689 [Package]; Contains: 00850018374682; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990878

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: 2020-08-10
• Device Publish Date: 2020-08-01

On-Brand Devices [NitriTech]

• 10850020255365: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850020255341: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850020255327: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850020255303: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850020255280: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850020255266: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850018374726: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850018374702: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850018374689: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850018374665: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850018374641: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin
• 10850018374627: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Fin