Dyna-Safety Nitrile Exam Gloves,Powder-Free,Blue,X-Large

GUDID 00840117334151

DYNAREX CORPORATION

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00840117334151
NIH Device Record Keyac28ac2d-95c2-406f-a068-3d2582c62b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyna-Safety Nitrile Exam Gloves,Powder-Free,Blue,X-Large
Version Model Number2624
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117334144 [Primary]
GS100840117334151 [Package]
Contains: 00840117334144
Package: MC Master [500 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 Date2024-03-26
Device Publish Date2024-03-18

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