GUDID 10850018374825

4mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Textured Fingertips, Powder Free, Aqua Green, Size 2X-Large

SUMMIT GLOVE INC.

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

• Primary Device ID: 10850018374825
• NIH Device Record Key: b2396c9a-7f27-4f39-940a-647c5a2d356b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CRI-550-AG-2XL
• Company DUNS: 054386458
• Company Name: SUMMIT GLOVE INC.
• Device Count: 135
• 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	00850018374828 [Primary]
GS1	00850018374835 [Unit of Use]
GS1	10850018374825 [Package]; Contains: 00850018374828; Package: Box [10 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

Devices Manufactured by SUMMIT GLOVE INC.

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