FDA.reportPublic FDA data

Eagle Heavy Duty Latex Examination Gloves

Primary DI
09421024254896
Brand
Eagle Heavy Duty Latex Examination Gloves
Company
Eagle Protect Pbc
Model
2XL
Catalog number
1130612
Device description
Heavy Duty Latex Examination Gloves, Blue, Powder-free, size 2XL
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19421024254893PackageGS110In Commercial Distribution
09421024254896PrimaryGS10
09421024251581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1942102425489319421024254893
09421024254896094210242548969421024254896
09421024251581094210242515819421024251581

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
800-384-3905info@eagleprotect.com

Regulatory Flags#

DUNS number
080473605
Device count
50
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421024254636Eagle Derma2 Nitrile Examination GlovesS11522122023-01-02
09421024254643Eagle Derma2 Nitrile Examination GlovesM11523122023-01-02
09421024254650Eagle Derma2 Nitrile Examination GlovesL11524122023-01-02
09421024254667Eagle Derma2 Nitrile Examination GlovesXL11525122023-01-02
09421024254674Eagle Derma2 Nitrile Examination Gloves2XL11526122023-01-02
19421024254633Eagle Derma2 Nitrile Examination GlovesS11522122023-01-02
19421024254640Eagle Derma2 Nitrile Examination GlovesM11523122023-01-02
19421024254657Eagle Derma2 Nitrile Examination GlovesL11524122023-01-02
19421024254664Eagle Derma2 Nitrile Examination GlovesXL11525122023-01-02
19421024254671Eagle Derma2 Nitrile Examination Gloves2XL11526122023-01-02
09421024254681Eagle Derma2 Nitrile Examination GlovesXS11521122023-01-02
09421024252823Eagle Sensitive Nitrile Examination GlovesS11612122022-12-07
09421024252830Eagle Sensitive Nitrile Examination GlovesM11613122022-12-07
09421024252847Eagle Sensitive Nitrile Examination GlovesL11614122022-12-07
09421024252854Eagle Sensitive Nitrile Examination GlovesXL11615122022-12-07
09421024252922Eagle Sensitive Nitrile Examination Gloves2XL11616122022-12-12
09421024254124Eagle Derma2 Nitrile Examination GlovesS11512122022-12-07
09421024254131Eagle Derma2 Nitrile Examination GlovesM11513122022-12-07
09421024254148Eagle Derma2 Nitrile Examination GlovesL11514122022-12-07
09421024254155Eagle Derma2 Nitrile Examination GlovesXL11515122022-12-07

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Primary DI, Brand, Company table
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09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
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