AmbiNitrile

GUDID 10850018374245

11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Green, Size Large

SUMMIT GLOVE INC.

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

• Primary Device ID: 10850018374245
• NIH Device Record Key: 9487be7a-93e8-4d55-8f84-ecd2776f7084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmbiNitrile
• Version Model Number: 570-GR-9
• Company DUNS: 054386458
• Company Name: SUMMIT GLOVE INC.
• Device Count: 24
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018374248 [Primary]
GS1	00850018374255 [Unit of Use]
GS1	10850018374245 [Package]; Contains: 00850018374248; Package: Box [24 Units]; In Commercial Distribution

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 [AmbiNitrile]

• 10850019992882: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992868: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992844: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992820: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992806: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992783: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992769: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992745: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992721: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850019992707: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374283: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374269: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374245: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374221: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374207: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374184: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374160: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374146: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374122: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter
• 10850018374108: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter