PureSense 1068401

GUDID D79010684013

PureSense Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material

PURELIFE, LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD79010684013
NIH Device Record Key329e674c-7648-495f-93af-a7aed55df2fc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureSense
Version Model Number1068401
Catalog Number1068401
Company DUNS828690904
Company NamePURELIFE, LLC
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79010684010 [Unit of Use]
HIBCCD79010684011 [Primary]
HIBCCD79010684013 [Package]
Contains: D79010684011
Package: Case [1000 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 Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [PureSense]

D79010684053PureSense Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Pink in color, Packaging con
D79010684043PureSense Nitrile Powder-Free, Large, Nitrile powder-free gloves, Pink in color, Packaging conta
D79010684033PureSense Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Pink in color, Packaging cont
D79010684023PureSense Nitrile Powder-Free, Small, Nitrile powder-free gloves, Pink in color, Packaging conta
D79010684013PureSense Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Pink in color, Packaging con

Trademark Results [PureSense]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PURESENSE
PURESENSE
97538948 not registered Live/Pending
Ersoy Mengulogul
2022-08-08
PURESENSE
PURESENSE
88920889 not registered Live/Pending
Ersoy Mengulogul
2020-05-18
PURESENSE
PURESENSE
88641175 not registered Live/Pending
Ersoy Mengulogul
2019-10-03
PURESENSE
PURESENSE
88120697 not registered Live/Pending
CHOU SHU-HSIEN
2018-09-17
PURESENSE
PURESENSE
88071406 not registered Live/Pending
Electrolux Home Products, Inc.
2018-08-09
PURESENSE
PURESENSE
87007580 5049893 Live/Registered
Jain Agriculture Services, LLC
2016-04-20
PURESENSE
PURESENSE
87007572 5049892 Live/Registered
Jain Agriculture Services, LLC
2016-04-20
PURESENSE
PURESENSE
86912127 5049328 Live/Registered
Jain Agriculture Services, LLC
2016-02-18
PURESENSE
PURESENSE
78183523 3032771 Dead/Cancelled
PURESENSE ENVIRONMENTAL, INC.
2002-11-10

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