OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves

Primary DI
00057565120971
Brand
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves
Company
A.M.G. Médicale Inc
Model
012-097
Device description
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
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00057565972389PackageGS110In Commercial Distribution
10057565120978PackageGS110In Commercial Distribution
05756512097148PrimaryGS10
00057565120971Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00057565972389000575659723890575659723890057565972389
1005756512097810057565120978
05756512097148057565120971485756512097148
00057565120971000575651209710575651209710057565120971

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
207372814
Device count
1
Lot or batch
true
Manufacturing date on label
true

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