SUMMIT GLOVE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15308823001732439SUMMIT GLOVE, INC.1Y2026-01-01310 S Grant Blvd MINERVA OH US 44657

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850020255801767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size 2X-Large"+1(330)868-0066klynn@summitglove.com
00850020255825767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size 3X-Large"+1(330)868-0066klynn@summitglove.com
00850020255849767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size Small Sample Pack"+1(330)868-0066klynn@summitglove.com
00850020255863767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size Medium Sample Pack"+1(330)868-0066klynn@summitglove.com
00850020255887767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size Large Sample Pack"+1(330)868-0066klynn@summitglove.com
00850020255900767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size X-Large Sample Pack"+1(330)868-0066klynn@summitglove.com
00850020255924767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size 2X-Large Sample Pack"+1(330)868-0066klynn@summitglove.com
00850020255948767PF Series - "4mil, 9.5"" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size 3X-Large Sample Pack"+1(330)868-0066klynn@summitglove.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
549801932654561K990878BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)LZA1999-05-21
549802055907000K133193RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)LZA2014-06-23
549801558858204K093517NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVELZA2010-06-29
549801116662078K093516NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVESLZA2010-06-29
549801636222999K060402BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)LZA2006-06-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA52014-06-23

PMN#

GUDID#

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