FDA.reportPublic FDA data

Disposable medical face masks

Primary DI
16945060520178
Brand
Disposable medical face masks
Company
Jiang Xi Sanxin Medtec Co., Ltd.
Model
Type A (ear-loop type),size II,Sterile 9.5×16 Leve
Device description
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.The non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile
Published
2025-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
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
K202719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202719000Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.2021-01-04FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16945060520178PackageGS150In Commercial Distribution
26945060520175PackageGS140In Commercial Distribution
06945060520171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694506052017816945060520178
2694506052017526945060520175
06945060520171069450605201716945060520171

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

Regulatory Flags#

DUNS number
530079367
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945060520010Disposable medical face masksType A (ear-loop type),Large size,Sterile 9.5×17.52025-03-19
06945060520027Disposable medical face masksType A (ear-loop type),Large size,Non-sterile 9.5×2025-03-19
06945060520034Disposable medical face masksType B (tie-on type),Large size,Sterile 9.5×17.5 L2025-03-19
06945060520041Disposable medical face masksType B(tie-on type),Large size,Non-sterile 9.5×17.2025-03-19
06945060520058Disposable medical face masksType A (ear-loop type),Medium Size,sterile 9.5×15.2025-03-19
06945060520065Disposable medical face masksType A (ear-loop type), Medium size,Non-sterile 9.2025-03-19
06945060520072Disposable medical face masksType B (tie-on type),Medium size,Sterile 9.5×15.5 2025-03-19
06945060520089Disposable medical face masksType B(tie-on type),Medium size,Non-sterile 9.5×152025-03-19
06945060520096Disposable medical face masksType A (ear-loop type),Small size,Sterile 9.5×14 L2025-03-19
06945060520102Disposable medical face masksType A (ear-loop type),Small size,Non-sterile 9.5×2025-03-19
06945060520119Disposable medical face masksType B(tie-on type),Small size,Sterile 9.5×14 Leve2025-03-19
06945060520126Disposable medical face masksType B (tie-on type),Small size,Non-sterile 9.5×142025-03-19
06945060520133Disposable medical face masksType A (ear-loop type),size I,Sterile 9.5×14.5 Lev2025-03-19
06945060520140Disposable medical face masksType A (ear-loop type),size I,Non-sterile 9.5×14.52025-03-19
06945060520157Disposable medical face masksType B (tie-on type),size I,Sterile 9.5×14.5 Level2025-03-19
06945060520164Disposable medical face masksType B (tie-on type),size I,Non-sterile 9.5×14.5 L2025-03-19
06945060520171Disposable medical face masksType A (ear-loop type),size II,Sterile 9.5×16 Leve2025-03-19
06945060520188Disposable medical face masksType A (ear-loop type),size II,Non-sterile 9.5×16 2025-03-19
06945060520195Disposable medical face masksType B (tie-on type),size II,Sterile 9.5×16 Level 2025-03-19
06945060520201Disposable medical face masksType B (tie-on type),size II,Non-sterile 9.5×16 Le2025-03-19

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