FDA.reportPublic FDA data

Disposable Surgical Face Mask

Primary DI
06970206825148
Brand
Disposable Surgical Face Mask
Company
Jiangsu NewValue Medical Products Co.,Ltd.
Model
EL-L03
Device description
regular pack: 50pcs/box, 40boxes/case
Published
2023-06-13
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
K202491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202491000Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd.2021-01-06FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970206825155PackageGS140In Commercial Distribution
06970206825148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970206825155069702068251556970206825155
06970206825148069702068251486970206825148

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.

Regulatory Flags#

DUNS number
544401775
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970206829191PreviClear Border Sacrum Transparent Gel DressingBorder2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingBorder2026-06-23
06970206820808kegel Hydrogel DressingIsland2026-06-22
06970206822390Rhino Rescue Hemostatic Dressing/2026-06-22
06970206823946Dr Perfect Hydrocolloid DressingIsland2026-06-22
06970206823960Dr Perfect Silicone Scar Sheets/2026-06-22
06970206823977kegel Hydrocolloid DressingIsland2026-06-22
06970206823984kegel Silicone Scar Sheets/2026-06-22
06970206827067Ourmed Foam DressingBorder2026-06-22
06970206827074Ourmed Foam DressingBorder2026-06-22
06970206827081Ourmed Foam DressingBorder2026-06-22
06970206827098Ourmed Foam DressingBorder2026-06-22
06970206827104Ourmed Foam DressingBorder2026-06-22
06970206827845SURESPOT Hemostatic Dressing/2026-06-22
06970206828149Ourmed Foam DressingBorder2026-06-22
06970206828156Ourmed Foam DressingBorder2026-06-22
06970206828163Ourmed Foam DressingBorder2026-06-22
06970206828170Ourmed Foam DressingBorder2026-06-22
06970206828217SURESPOT Hemostatic Dressing/2026-06-22
06970206828224SURESPOT Hemostatic Dressing/2026-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05