AmerCareRoyal Powder-Free Nitrile Exam Gloves

GUDID 00811033012447

Amercareroyal, LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00811033012447
NIH Device Record Key2a79d895-9b57-4a3b-b724-52ab3453780c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmerCareRoyal Powder-Free Nitrile Exam Gloves
Version Model Number14002
Company DUNS002326965
Company NameAmercareroyal, LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811033012447 [Package]
Contains: 00811033012492
Package: Carton [10 Units]
In Commercial Distribution
GS100811033012492 [Primary]

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 Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [AmerCareRoyal Powder-Free Nitrile Exam Gloves]

0081103301489214005
0081103301246114004
0081103301245414003
0081103301244714002
0081103301243014001
0081103301242314000

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