N-Dex M7005PFL

GUDID 20038054686493

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

SHOWA BEST GLOVE, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID20038054686493
NIH Device Record Key75477bda-2ec4-4054-bed8-70d1940b61c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameN-Dex
Version Model NumberL
Catalog NumberM7005PFL
Company DUNS807930412
Company NameSHOWA BEST 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

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
GS100038054686499 [Primary]
GS110038054686496 [Unit of Use]
GS120038054686493 [Package]
Contains: 00038054686499
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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