NitriTech Ultra

GUDID 10850018374405

6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish, Single Use, Beaded Cuff, Blue, Size 3X-Large

SUMMIT GLOVE INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10850018374405
NIH Device Record Key01cd5e7f-0a56-4513-8e9d-f8af75afa050
Commercial Distribution StatusIn Commercial Distribution
Brand NameNitriTech Ultra
Version Model Number61070PF-3XL
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018374408 [Primary]
GS100850018374415 [Unit of Use]
GS110850018374405 [Package]
Contains: 00850018374408
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

On-Brand Devices [NitriTech Ultra]

108500202550446mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500202550206mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500202550066mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500199929816mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500199929436mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500199929296mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500199929056mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183744296mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183744056mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183743826mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183743686mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183743446mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183743206mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
108500183743066mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish
015001999296056mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.