FDA.reportPublic FDA data

Surgical Mask

Primary DI
00883940405148
Brand
Surgical Mask
Company
Honeywell Safety Products USA, Inc.
Model
559250P
Catalog number
559250P
Published
2021-04-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201479000DemeMASKDemetech Corporation2020-07-24FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883940405148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883940405148008839404051488839404051480883940405148

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
198541331
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883940421698Honeywell Performance Exam Glove4580601–M 2022-02-25
00883940421711Honeywell Performance Exam Glove4580601-L2022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
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