FDA.reportPublic FDA data

Protect U Guard Tie On Face Mask 3 Ply Green

Primary DI
B086100431
Brand
Protect U Guard Tie On Face Mask 3 Ply Green
Company
PROTECT U GUARD, LLC
Model
P10043
Published
2017-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K153409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153409000Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC2016-11-15FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B086100431PrimaryHIBCC0
B086100430Unit of UseHIBCC0

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
080070945
Device count
50
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
B086191501Protect U Guard U-Shaped IV Transparent DressingP191502020-08-21
B086191511Protect U Guard Transparent Sterile DressingP191512020-08-21
B086191541Protect U Guard Transparent Sterile Dressing PU InciseP191542020-08-21
B086202012Protect U Guard Bouffant Cap BlueP202012017-02-24
B086202022Protect U Guard Bouffant Cap YellowP202022017-02-24
B086203012Protect U Guard Doctor Cap BlueP203012017-02-24
B086191311Protect U Guard Silicone Foam Sterile DressingP191312020-08-21
B086191321Protect U Guard Silicone Foam Sterile DressingP191322020-08-21
B086105051Protect U Guard CPE Isolation GownP105052021-02-02
B086205052Protect U Guard CPE Isolation GownP105052021-02-02
B086191001Protect U Guard Hydrocolloid Sterile DressingP191002020-08-21
B086191011Protect U Guard Hydrocolloid Sterile DressingP191012020-08-21
B086191021Protect U Guard Hydrocolloid Sterile DressingP191022020-08-21
B086191031Protect U Guard Hydrocolloid Sterile DressingP191032020-08-21
B086191041Protect U Guard Hydrocolloid With Foam Backing Sterile DressingP191042020-08-21
B086191101Protect U Guard Alginate Sterile DressingP191102020-08-21
B086191111Protect U Guard Alginate Sterile DressingP191112020-08-21
B086191121Protect U Guard Alginate Sterile DressingP191122020-08-21
B086191231Protect U Guard Non-Woven DressingP191232020-08-21
B086191241Protect U Guard Non-Woven DressingP291242020-08-21

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