Get-A-Grip

GUDID 10850020255624

5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern, Beaded Cuff, Black, Size Medium Sample Pack

SUMMIT GLOVE INC.

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

• Primary Device ID: 10850020255624
• NIH Device Record Key: 8bb4c551-93f7-45e0-aca1-2f00b318be9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Get-A-Grip
• Version Model Number: 79730PF-BKGR
• Company DUNS: 054386458
• Company Name: SUMMIT GLOVE INC.
• Device Count: 4
• 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
• 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	00850020255627 [Primary]
GS1	00850020255634 [Unit of Use]
GS1	10850020255624 [Package]; Contains: 00850020255627; Package: Box [1200 Units]; 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 [Get-A-Grip]

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• 10850020255709: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255686: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255662: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255648: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255624: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255600: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255587: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255563: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255549: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255525: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255501: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
• 10850020255488: 5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern
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• 00150042054322: Get-A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentan
• 00150042054308: Get-A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentan
• 00150042054285: Get-A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentan
• 00150042054261: Get-A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentan
• 00150042054247: Get-A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentan
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• 00150042054636: Get-A-Grip Nitrile Two-Toned Blue/Green Powder Free,Exam Grade Glove,Tested for use with Fentany
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