FDA.reportPublic FDA data

Eagle Sensitive Nitrile Examination Gloves

Primary DI
09421024252816
Brand
Eagle Sensitive Nitrile Examination Gloves
Company
Eagle Protect Pbc
Model
XS
Catalog number
1161112
Device description
Sensitive Nitrile Gloves, size XS, Nitrile Powder-free examination glove
Published
2022-12-07
Public version status
Update
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
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19421024252813PackageGS110In Commercial Distribution
09421024252816PrimaryGS10
09421024254704Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1942102425281319421024252813
09421024252816094210242528169421024252816
09421024254704094210242547049421024254704

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080473605
Device count
100
No 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.QDO2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.QDO2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.QDO2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06