FDA.reportPublic FDA data

ICON CERTO

Primary DI
B958ESS60BN4101
Brand
ICON CERTO
Company
Excel Gloves & Safety Supplies, Inc.
Model
FORTE ESS60BN410
Catalog number
ESS60BN410
Device description
GLOVES, EXAMINATION POWDER-FREE TEXTURED, FENTANYL TESTED, EXTRA, EXTRA LARGE ESS60BN410 (2XL)
Published
2023-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B958ESS60BN4101PrimaryHIBCC0
B958ESS60BN410Unit of UseHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
253-896-1195glovelady@excelsupplycompany.com

Regulatory Flags#

DUNS number
928913409
Device count
90
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
B958EB3310EXCEL Bio GlovesEB3310EB33102025-09-16
B958EB336EXCEL Bio GlovesEB336EB3362025-09-16
B958EB337EXCEL Bio GlovesEB337EB3372025-09-16
B958EB338EXCEL Bio GlovesEB338EB3382025-09-16
B958EB339EXCEL Bio GlovesEB339EB3392025-09-16
B958FM388BLK1Procedure Mask 3 ply level 1, color 50 per box, BLACKFM BLACK2024-09-06
B958FM388G1EXCEL Procedure Mask 3 ply level 1, 50 per box, mint greenFM 388G Mint Green0503FM388G2024-09-06
B958FM3881Procedure Mask 3 ply level 1, color 50 per box, BLACKFM BLACK2024-09-06
B95848861ICONICON 4886ICON48862023-08-02
B958E20861EXCELEXCEL E2086EXCEL E20862023-08-02
B958E20871EXCELEXCEL E2087EXCEL E20872023-08-02
B958E20881EXCELEXCEL E2088EXCEL E20882023-08-02
B958EM18871EXCELEXCEL EM1887EM18872023-08-02
B958EM18881EXCELEXCEL EM1888EM18882023-08-02
B958EM18891EXCELEXCEL EM1889EM18892023-08-02
B958EPF28861EXCELPRIMERA EPF2886EPF28862023-08-02
B958EPF28871EXCELPRIMERA EPF2887EPF28872023-08-02
B958EPF28881EXCELPRIMERA EPF2888EPF28882023-08-02
B958EPF28891EXCELPRIMERA EPF2889EPF28892023-08-02
B958ESL8100101EXCELAXON ESL810010ESL810092023-08-02

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