FDA.reportPublic FDA data

Surgical Face Mask

Primary DI
06973062321564
Brand
Surgical Face Mask
Company
Foshan Nanhai Plus Medical Co., Ltd
Model
533-003
Published
2022-02-21
Public version status
New
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
K212610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212610000Surgical Face MaskFoshan Nanhai Plus Medical Co, Ltd.2022-01-26FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973062321561PackageGS130In Commercial Distribution
26973062321568PackageGS150In Commercial Distribution
06973062321564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697306232156116973062321561
2697306232156826973062321568
06973062321564069730623215646973062321564

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.

Regulatory Flags#

DUNS number
529796225
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973062320406Standard Surgical Gown (AAMI Level 2)PM3501SGN2026-04-24
06973062320413Standard Surgical Gown (AAMI Level 2)PM3502SGN2026-04-24
06973062320420Standard Surgical Gown (AAMI Level 2)PM3503SGN2026-04-24
06973062320437Standard Surgical Gown (AAMI Level 2)PM3504SGN2026-04-24
06973062320444Standard Surgical Gown (AAMI Level 2)PM3505SGN2026-04-24
06973062320451Standard Surgical Gown (AAMI Level 2)PM3501SGS2026-04-24
06973062320468Standard Surgical Gown (AAMI Level 2)PM3502SGS2026-04-24
06973062320475Standard Surgical Gown (AAMI Level 2)PM3503SGS2026-04-24
06973062320482Standard Surgical Gown (AAMI Level 2)PM3504SGS2026-04-24
06973062320499Standard Surgical Gown (AAMI Level 2)PM3505SGS2026-04-24
06973062320505Reinforced Surgical Gown (AAMI Level 2)PM3501RGN2026-04-24
06973062320512Reinforced Surgical Gown (AAMI Level 2)PM3502RGN2026-04-24
06973062320529Reinforced Surgical Gown (AAMI Level 2)PM3503RGN2026-04-24
06973062320536Reinforced Surgical Gown (AAMI Level 2)PM3504RGN2026-04-24
06973062320543Reinforced Surgical Gown (AAMI Level 2)PM3505RGN2026-04-24
06973062320550Reinforced Surgical Gown (AAMI Level 2)PM3501RGS2026-04-24
06973062320567Reinforced Surgical Gown (AAMI Level 2)PM3502RGS2026-04-24
06973062320574Reinforced Surgical Gown (AAMI Level 2)PM3503RGS2026-04-24
06973062320581Reinforced Surgical Gown (AAMI Level 2)PM3504RGS2026-04-24
06973062320598Reinforced Surgical Gown (AAMI Level 2)PM3505RGS2026-04-24

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