GUDID 10850018374801

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

SUMMIT GLOVE INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10850018374801
NIH Device Record Key83df981c-4086-433a-8128-1471c7596364
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCRI-550-AG-XL
Company DUNS054386458
Company NameSUMMIT GLOVE INC.
Device Count135
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018374804 [Primary]
GS100850018374811 [Unit of Use]
GS110850018374801 [Package]
Contains: 00850018374804
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

LZAPolymer patient examination glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-08-01

Devices Manufactured by SUMMIT GLOVE INC.

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00150062224309 - Get-A-Grip2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size XXXL
00150062224323 - Get-A-Grip2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size S CTN
00150062224347 - Get-A-Grip2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size M CTN

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