FDA.reportPublic FDA data

EcoGuard® Surgical Mask

Primary DI
B927200206830
Brand
EcoGuard® Surgical Mask
Company
Ecoguard, Inc
Model
EcoGuard B
Catalog number
20020683
Device description
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B927200206832PackageHIBCC40In Commercial Distribution
B927200206831PrimaryHIBCC0
B927200206830Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(704)322-3709cs@ecoguard.us

Regulatory Flags#

DUNS number
117512312
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B927200206711EcoGuard® Surgical Mask EcoGuard B200206712024-06-05
B927200206831EcoGuard® Surgical Mask EcoGuard B200206832024-06-05
B927200289931EcoGuard® Surgical Mask EcoGuard B200289932024-06-05
B927200292191EcoGuard® Surgical Mask EcoGuard B200292192024-06-05
B927200292701EcoGuard® Surgical Mask EcoGuard B200292702024-06-05
B927200292711EcoGuard® Surgical Mask EcoGuard B200292712024-06-05
B927200292721EcoGuard® Surgical Mask EcoGuard B200292722024-06-05
B927200292731EcoGuard® Surgical Mask EcoGuard B200292732024-06-05
B927200292741EcoGuard® Surgical Mask EcoGuard B200292742024-06-05
B927200292751EcoGuard® Surgical Mask EcoGuard B200292752024-06-05
B927200292761EcoGuard® Surgical Mask EcoGuard B200292762024-06-05
B927200292771EcoGuard® Surgical Mask EcoGuard B200292772024-06-05
B927200292781EcoGuard® Surgical Mask EcoGuard B200292782024-06-05
B927200292791EcoGuard® Surgical Mask EcoGuard B200292792024-06-05
B927200292801EcoGuard® Surgical Mask EcoGuard B200292802024-06-05
B927200206712EcoGuard® Surgical Mask EcoGuard B200206712024-06-05
B927200289930EcoGuard® Surgical Mask EcoGuard B200289932024-06-05
B927200292192EcoGuard® Surgical Mask EcoGuard B200292192024-06-05
B927200292702EcoGuard® Surgical Mask EcoGuard B200292702024-06-05
B927200292710EcoGuard® Surgical Mask EcoGuard B200292712024-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
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10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
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10304040168582CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
10096295122296LeaderShepard Medical Products, Inc.FXX2023-01-06
10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06