FDA.reportPublic FDA data

OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves

Primary DI
10057565121173
Brand
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves
Company
A.M.G. Médicale Inc
Model
012-117
Device description
Customer focused packaging with attractive, easy to read boxes. Flexible packaging allowing vertical or horizontal merchandising increasing shop-ability while reducing shelf and storage space Ergonomic opening to avoid waste Recyclable packaging Comfortable fit Latex-free and powder-free for low allergy or dermatitis potential Beaded cuff to prevent roll-down Snug fit for good sensation and grip Meets or exceeds ASTM standards for Medical Exam gloves Ideal for use with chemicals that will compromise vinyl and latex gloves ASTM F1671 - Penetration by Blood-Borne Pathogens ASTM D6319 - Specification for Nitrile Examination Gloves for Medical Application Chemotherapy 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
Rx
false
OTC
false
Sterile
false
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
10057565121173PackageGS110In Commercial Distribution
00057565121176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005756512117310057565121173
00057565121176000575651211760575651211760057565121176

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
207372814
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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00057565166290Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565166481ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565166498ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
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00775757713151Avantia Portable Steel Commode771-3152020-04-16
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00057565975120PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565972846Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565972853Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565973447ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565973461ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565166252PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09

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