767PF Series

GUDID 10850020255822

4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size 3X-Large

SUMMIT GLOVE INC.

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

• Primary Device ID: 10850020255822
• NIH Device Record Key: 69cc1b61-f102-407d-969a-f08fef875eaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 767PF Series
• Version Model Number: 76770PF-3XL
• 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	00850020255825 [Primary]
GS1	00850020255832 [Unit of Use]
GS1	10850020255822 [Package]; Contains: 00850020255825; 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: 2020-08-25
• Device Publish Date: 2020-08-17

On-Brand Devices [767PF Series]

• 10850020255945: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255921: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255907: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255884: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255860: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255846: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255822: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255808: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255785: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255761: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255747: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
• 10850020255723: 4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,