FDA.reportPublic FDA data

EnSure

Primary DI
10857420007600
Brand
EnSure
Company
ECON DISPOSABLE SUPPLIES, INC
Model
ESN220-BX
Device description
Nitrile Powder Free Examination Gloves, XS, 200/BX, Tested for Use with Chemotherapy Drugs, Low Dermatitis Potential
Published
2026-01-09
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
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
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
20857420007607PackageGS110In Commercial Distribution
10857420007600PrimaryGS10
00857420007603Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085742000760720857420007607
1085742000760010857420007600
00857420007603008574200076038574200076030857420007603

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.

Regulatory Flags#

DUNS number
018198668
Device count
200
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094090869ShieldMaxxHD151-BX2026-02-01
00810094090876ShieldMaxxHD152-BX2026-02-01
00810094090883ShieldMaxxHD153-BX2026-02-01
00810094090890ShieldMaxxHD154-BX2026-02-01
00810094090906ShieldMaxxHD155-BX2026-02-01
00810094090913ShieldMaxxHD151-BX2026-02-01
00810094090920ShieldMaxxHD152-BX2026-02-01
00810094090937ShieldMaxxHD153-BX2026-02-01
00810094090944ShieldMaxxHD154-BX2026-02-01
00810094090951ShieldMaxxHD155-BX2026-02-01
10857420007617EnSureESN221-BX2026-01-09
10857420007624EnSureESN222-BX2026-01-09
10857420007631EnSureESN223-BX2026-01-09
10857420007648EnSureESN224-BX2026-01-09
20857420007607EnSureESN220-BX2026-01-09
00857420007610EnSureESN221-BX2026-01-09
20857420007621EnSureESN222-BX2026-01-09
20857420007638EnSureESN223-BX2026-01-09
20857420007645EnSureESN224-BX2026-01-09
00810094090296EnSureESN703-BX2025-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502418HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502418HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502425HalyardO&M HALYARD, INC.OPJ2026-06-04