FDA.report

MICROFLEX

Primary DI
00769799205002
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
EV-2050-XL
Catalog number
EV-2050-XL
Device description
MICROFLEX EV-2050 EVOLUTION ONE SIZE XL (9.5-10.0), Latex Powder-Free Examination Glove
Published
2022-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYYLatex Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00769799205002PackageGS110In Commercial Distribution
00769799205057PrimaryGS10
00071483002720Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00769799205002007697992050027697992050020769799205002
00769799205057007697992050577697992050570769799205057
00071483002720000714830027200714830027200071483002720

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
775-746-6600jacob.ramirez@ansell.com

Regulatory Flags

DUNS number
111267330
Device count
100
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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20076490748658KIMTECH55090550902025-07-03
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20076490754888KIMTECH50706507062025-07-03

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