FDA.reportPublic FDA data

StringKing

Primary DI
00195376202674
Brand
StringKing
Company
String King Lacrosse LLC
Model
20267
Catalog number
DMM.L2.A.WHT.1
Device description
3 Layer Surgical Mask, Level 2, White
Published
2021-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K202607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202607000Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcsString King Lacrosse, LLC2021-04-23FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30195376202675PackageGS120In Commercial Distribution
00195376202674PrimaryGS10
00195376202698Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019537620267530195376202675
00195376202674001953762026741953762026740195376202674
00195376202698001953762026981953762026980195376202698

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.

Contacts#

Phone, Email table
PhoneEmail
+1 310 795 4424info@stringking.com

Regulatory Flags#

DUNS number
065807495
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195376201844StringKingDIG.SMS.L2.L.BLU2022-07-18
00195376201851StringKingDIG.SMS.L2.XL.BLU2022-07-18
10195376202121StringKing20212DSG.SMS.L3.S.BLU2021-08-03
10195376202145StringKing20214DSG.SMS.L3.M.BLU2021-08-03
10195376202169StringKing20216DSG.SMS.L3.XL.BLU2021-08-03
10195376202244StringKing20224DSG.SMS.L4.S.BLU2021-09-17
10195376202251StringKing20225DSG.SMS.L4.M.BLU2021-09-17
10195376202268StringKing20226DSG.SMS.L4.L.BLU2021-09-17
10195376202275StringKing20227DSG.SMS.L4.XL.BLU2021-09-17
10195376202282StringKing20228DSG.SMS.L4.XXL.BLU2021-09-17
10195376202114StringKing20211DSG.SMS.L3.L.BLU2021-08-03
10195376202183StringKing20218DSG.SMS.L3.XXL.BLU2021-08-03
10195376201841StringKingDIG.SMS.L2.L.BLU2022-07-18
10195376201858StringKingDIG.SMS.L2.XL.BLU2022-07-18
00195376202216StringKing20221DMM-L3-A-BLU2021-09-09
00195376202667StringKing20266DMM-L2-A-BLU2021-12-04
30195376202668StringKing20266DMM.L2.A.BLU.12021-12-04
30195376202675StringKing20267DMM.L2.A.WHT.12021-12-04
30195376202248StringKing202242021-09-17
30195376202255StringKing202252021-09-17

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