FDA.reportPublic FDA data

ShieldMaxx

Primary DI
00810094090890
Brand
ShieldMaxx
Company
ECON DISPOSABLE SUPPLIES, INC
Model
HD154-BX
Device description
High Risk Powder Free Latex Exam Gloves, Blue, XL, 50/BX, Long Cuff
Published
2026-02-01
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
LYYLatex Patient Examination Glove
LZCMedical 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
00810094090944PackageGS110In Commercial Distribution
00810094090890PrimaryGS10
00810094090845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094090944008100940909448100940909440810094090944
00810094090890008100940908908100940908900810094090890
00810094090845008100940908458100940908450810094090845

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Condition, Specify: Store 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
50
Lot or batch
true
Manufacturing date on label
true
Contains 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
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
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
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
10810141933740VIVIT SupplyVivit Supply LLCLZC2026-02-03
10810141933757VIVIT SupplyVivit Supply LLCLZC2026-02-03
10810141933764VIVIT SupplyVivit Supply LLCLZC2026-02-03
10810141933771VIVIT SupplyVivit Supply LLCLZC2026-02-03