ResQ-Grip

GUDID 10850019992189

5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern, Beaded Cuff, Black, Size 3X-Large

SUMMIT GLOVE INC.

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

• Primary Device ID: 10850019992189
• NIH Device Record Key: f4c86892-31c5-4401-9cc7-830183563a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResQ-Grip
• Version Model Number: 79770PF-BKGR
• Company DUNS: 054386458
• Company Name: SUMMIT GLOVE INC.
• Device Count: 90
• 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	00850019992182 [Primary]
GS1	00850019992199 [Unit of Use]
GS1	10850019992189 [Package]; Contains: 00850019992182; Package: Box [10 Units]; Discontinued: 2020-08-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060402

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 [ResQ-Grip]

• 10850019992189: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992165: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992141: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019922124: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992103: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992080: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992066: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992042: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992028: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850019992004: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850018374986: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850018374962: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern