Safe-Touch Blue Nitrile Examination Gloves

GUDID 00616784251219

Safe-Touch Blue Nitrile Examination Gloves, Powder Free, Medium, Ambidextrous

DYNAREX CORPORATION

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00616784251219
NIH Device Record Key5afb75d2-b473-4acd-b9aa-50a3aa96228c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafe-Touch Blue Nitrile Examination Gloves
Version Model Number2512
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784251219 [Unit of Use]
GS100616784251226 [Primary]
GS100616784251233 [Package]
Contains: 00616784251226
Package: Case [10 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 Date2022-05-02
Device Publish Date2022-04-22

On-Brand Devices [Safe-Touch Blue Nitrile Examination Gloves]

00616784251417Safe-Touch Blue Nitrile Examination Gloves, Powder Free, X-Large, Ambidextrous
00616784251318Safe-Touch Blue Nitrile Examination Gloves, Powder Free, Large, Ambidextrous
00616784251219Safe-Touch Blue Nitrile Examination Gloves, Powder Free, Medium, Ambidextrous
00616784251110Safe-Touch Blue Nitrile Examination Gloves, Powder Free, Small, Ambidextrous

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