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Summit Glove Inc.

United StatesFDA applicant, unverified

Summit Glove Inc. is a medical device manufacturer, with 245 devices listed in FDA GUDID and FDA 510(k) (FDA Class I) as of 12 Nov 2026.

Devices
245

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 240
  • FDA 510(k) 5

A device listed in two registries counts in both.

Device classes
  • FDA Class I 245
Identifiers
  • DUNS 054386458

What Summit Glove Inc. makes

Summit Glove Inc. manufactures examination and treatment gloves, including nitrile and hevea-latex varieties, all of which are non-powdered and non-antimicrobial. Their product line includes single-use gloves designed for medical, dental, and laboratory procedures, with specific models like NitriTech, AdvanceFit, and Get-A-Grip. The company also produces AmbiCanner, a glove-related accessory for improved fit and dexterity.

These devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer operates from the United States, adhering to applicable regulatory requirements for medical gloves.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue245

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Company details

DUNS number
054386458
Phone
3308680066

Frequently asked questions

How many devices does SUMMIT GLOVE INC. have in the registry?

The registry currently lists 245 devices for SUMMIT GLOVE INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list SUMMIT GLOVE INC.'s devices?

Among its 50 most recently registered devices, SUMMIT GLOVE INC. has devices listed in FDA GUDID (50 devices).

What risk classes do SUMMIT GLOVE INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for SUMMIT GLOVE INC.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from SUMMIT GLOVE INC. in the registry?

The most recently registered devices listed for SUMMIT GLOVE INC. include NitriTech 76760PF-2XL, AdvanceFit 650-LB-2XL, AdvanceFit 650-BK-2XL and Get-A-Grip 79760PF-BKGR.

Generated automatically from registry data and not verified by a human reviewer.