OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves - Blue, Extra SmallPacked: 100 / Box, 10 boxes / - A.M.G. Médicale Inc

Duns Number:207372814

Device Description: Blue, Extra SmallPacked: 100 / Box, 10 boxes / caseCustomer focused packagingAttractive, e Blue, Extra SmallPacked: 100 / Box, 10 boxes / caseCustomer focused packagingAttractive, easy to read boxesFlexible packaging allowing vertical or horizontal merchandising increasing shop-ability while reducing shelf and storage spaceErgonomic opening to avoid wasteRecyclable packagingComfortable fitLatex-free and powder-free for low allergy or dermatitis potentialBeaded cuff to prevent roll-downSnug fit for good sensation and gripMeets or exceeds ASTM standards for Medical Exam glovesIdeal for use with chemicals that will compromise vinyl and latex glovesASTM F1671 - Penetration by Blood-Borne PathogensASTM D6319 - Specification for Nitrile Examination Gloves for Medical ApplicationChemotherapy tested using ASTM D6978

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More Product Details

Catalog Number

-

Brand Name

OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves

Version/Model Number

012-097

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110981,K110981,K110981

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

c271d737-7977-4b95-bc7a-188694c33634

Public Version Date

August 21, 2020

Public Version Number

3

DI Record Publish Date

March 05, 2020

Additional Identifiers

Package DI Number

00057565972389

Quantity per Package

10

Contains DI Package

00057565120971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"A.M.G. MÉDICALE INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1