OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro

Primary DI
00057565121374
Brand
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro
Company
A.M.G. Médicale Inc
Model
012-137
Device description
Customer focused packaging with attractive, 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
2020-09-15
Public version status
New
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
10057565121371PackageGS110In Commercial Distribution
00057565121374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005756512137110057565121371
00057565121374000575651213740575651213740057565121374

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA 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.

Regulatory Flags#

DUNS number
207372814
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

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00057565166481ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565166498ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
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00057565972853Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
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00057565973461ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
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