N-Dex M7005PFXXL

GUDID 20038054686417

Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/Extra Extra Large

SHOWA BEST GLOVE, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID20038054686417
NIH Device Record Keybca0621d-dfee-4d71-99d4-ad8d79990b59
Commercial Distribution StatusIn Commercial Distribution
Brand NameN-Dex
Version Model NumberXXL
Catalog NumberM7005PFXXL
Company DUNS807930412
Company NameSHOWA BEST GLOVE, INC.
Device Count90
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

Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com
Phone800-241-0323
EmailUSA@Showagroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100038054686413 [Primary]
GS110038054686410 [Unit of Use]
GS120038054686417 [Package]
Contains: 00038054686413
Package: [20 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 Date2023-02-28
Device Publish Date2023-02-20

On-Brand Devices [N-Dex]

20038054686493Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/
20038054686486Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/
20038054686479Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/
20038054686462Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/
20038054686417Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/
20038054686400Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/

Trademark Results [N-Dex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
N-DEX
N-DEX
85629273 4278853 Live/Registered
Showa Glove Co.
2012-05-18
N-DEX
N-DEX
74201136 1701906 Live/Registered
SHOWA GLOVE CO.
1991-09-06

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