FDA.reportPublic FDA data

EnSure

Primary DI
10857420007617
Brand
EnSure
Company
ECON DISPOSABLE SUPPLIES, INC
Model
ESN221-BX
Device description
Nitrile Powder Free Examination Gloves, S, 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
10857420007617PrimaryGS10
00857420007610Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085742000761710857420007617
00857420007610008574200076108574200076100857420007610

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
10857420007600EnSureESN220-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
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08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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