FDA.report

KP Protective Face Mask

Primary DI
08809755250164
Company
KP trading Co., Ltd.
Model
Large-White
Device description
KP Protective Face Mask is a single-use, disposable surgical face mask intended to be worn by healthcare professionals to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. The mask covers the nose and mouth and is secured with ear loops. It is intended for use in medical and surgical settings. The mask is non-sterile and for single use only.
Published
2026-02-19
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

Related Records

Regulatory Flags

DUNS number
695645209
Device count
1
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
08809755250164PackageGS150In Commercial Distribution
08809755250171PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
08809755250164PackageGS150Box08809755250171In Commercial Distribution
08809755250171PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FXXMask, Surgical2General, Plastic Surgery878.4040NEligible

Premarket Submissions

SubmissionSupplement
K243342000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243342000KP Protective Face MaskKp Trading Co., Ltd.2025-12-22FXX

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+0314951042Jihyekwon@kptrading.co.kr

Other Devices From This Company

No records found.

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