790071

GUDID B3407900ML1

Large Synthetic Vinyl Powder Free Exam Glove

IMPACT PRODUCTS, LLC

Vinyl examination/treatment glove, non-powdered
Primary Device IDB3407900ML1
NIH Device Record Key3f07540a-239f-48c0-8082-66ff945930ee
Commercial Distribution StatusIn Commercial Distribution
Version Model Number790071M
Catalog Number790071
Company DUNS005052360
Company NameIMPACT PRODUCTS, 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 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
HIBCCB3407900ML1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYZVinyl 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 Date2020-07-06
Device Publish Date2020-06-26

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