FDA.reportPublic FDA data

Fluidproof

Primary DI
D832MK110N1
Brand
Fluidproof
Company
PLASDENT CORPORATION
Model
MK1-10N
Catalog number
MK1-10N
Device description
Earloop Mask, Neon Purple
Published
2022-02-25
Public version status
Update
Distribution status
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
K133070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133070000SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd.2015-06-22FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832MK110N2PackageHIBCC20In Commercial Distribution
D832MK110N1PrimaryHIBCC0
D832MK110N0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, antimicrobialA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is designed to create an airtight seal against the user’s face and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Regulatory Flags#

DUNS number
190377184
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832BLT100501PlasdentBLT-100-50BLT-100-502026-05-28
D832BEE0001PlasdentBEE-000BEE-0002026-05-06
D832BEE0011PlasdentBEE-001BEE-0012026-05-06
D832BEE0021PlasdentBEE-002BEE-0022026-05-06
D832906CDG20Plasdent906CDG2906CDG22026-05-01
D832906CDG30Plasdent906CDG3906CDG32026-05-01
D832BLT1011PlasdentBLT-101BLT-1012026-05-01
D832BLT2001PlasdentBLT-200BLT-2002026-05-01
D832BLT2011PlasdentBLT-201BLT-2012026-05-01
D832BLT3001PlasdentBLT-300BLT-3002026-05-01
D832BLT3011PlasdentBLT-301BLT-3012026-05-01
D832BLT3021PlasdentBLT-302BLT-3022026-05-01
D832BLT4181PlasdentBLT-418BLT-4182026-05-01
D832BLT4201PlasdentBLT-420BLT-4202026-05-01
D832BLT4211PlasdentBLT-421BLT-4212026-05-01
D832BLT4221PlasdentBLT-422BLT-4222026-05-01
D832BLT4231PlasdentBLT-423BLT-4232026-05-01
D832BLT4251PlasdentBLT-425BLT-4252026-05-01
D832BLT4271PlasdentBLT-427BLT-4272026-05-01
D832BLT5221PlasdentBLT-522BLT-5222026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040165260CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168483CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
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