Protect U Guard Nitro-Lion Nitrile Patient Examina

GUDID B086201042

Nitrile Patient Examination Glove, Indigo, Extra Large

PROTECT U GUARD, LLC

Nitrile examination/treatment glove, non-powdered, non-sterile
Primary Device IDB086201042
NIH Device Record Key93283bed-9a8b-4e5f-954e-7997cc5ee9fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtect U Guard Nitro-Lion Nitrile Patient Examina
Version Model NumberP20104
Company DUNS080070945
Company NamePROTECT U GUARD, LLC
Device Count2000
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-Countertrue

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB086101040 [Unit of Use]
HIBCCB086201042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZCPatient Examination Glove, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-02

On-Brand Devices [Protect U Guard Nitro-Lion Nitrile Patient Examina]

B086201142Nitrile Patient Examination Glove, White, Extra Large
B086201132Nitrile Patient Examination Glove, White, Large
B086201122Nitrile Patient Examination Glove, White, Medium
B086201112Nitrile Patient Examination Glove, White, Small
B086201042Nitrile Patient Examination Glove, Indigo, Extra Large
B086201032Nitrile Patient Examination Glove, Indigo, Large
B086201022Nitrile Patient Examination Glove, Indigo, Medium
B086201012Nitrile Patient Examination Glove, Indigo, Small
B086101141Nitrile Patient Examination Glove, White, Extra Large
B086101131Nitrile Patient Examination Glove, White, Large
B086101121Nitrile Patient Examination Glove, White, Medium
B086101111Nitrile Patient Examination Glove, White, Small
B086101041Nitrile Patient Examination Glove, Indigo, Extra Large
B086101031Nitrile Patient Examination Glove, Indigo, Large
B086101021Patient Examination Glove, Indigo, Medium
B086101011Nitrile Patient Examination Glove, Indigo, Small

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