767PF Series

GUDID 10850020255785

4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size X-Large

SUMMIT GLOVE INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10850020255785
NIH Device Record Key1ed96c58-683f-4a20-a5bf-434ad7a23c86
Commercial Distribution StatusIn Commercial Distribution
Brand Name767PF Series
Version Model Number76750PF-XL
Company DUNS054386458
Company NameSUMMIT GLOVE INC.
Device Count100
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
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
GS100850020255788 [Primary]
GS100850020255795 [Unit of Use]
GS110850020255785 [Package]
Contains: 00850020255788
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-08-25
Device Publish Date2020-08-17

On-Brand Devices [767PF Series]

108500202559454mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202559214mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202559074mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202558844mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202558604mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202558464mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202558224mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202558084mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202557854mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202557614mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202557474mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,
108500202557234mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue,

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