FDA.reportPublic FDA data

KIMBERLY-CLARK® Soft Touch™ II Surgical Mask

Primary DI
00036000475005
Brand
KIMBERLY-CLARK® Soft Touch™ II Surgical Mask
Company
KIMBERLY-CLARK GLOBAL SALES, LLC
Model
47500
Device description
Surgical Mask
Published
2016-11-30
Public version status
Update
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
K823078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823078000SPUNGUARD FACE MASKKimberly-Clark Corp.1983-01-07FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036000475002PackageGS16In Commercial Distribution
00036000475005PrimaryGS10
90036000475008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600047500210036000475002
00036000475005000360004750050360004750050036000475005
9003600047500890036000475008

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)346-4652xxx@xxx.xxx

Regulatory Flags#

DUNS number
830997032
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
00036000434378KIMTECH SPRING GREEN NITRILE POWDER FREE EXAM GLOVES (XS)4343743437-532020-03-13
00036000434385KIMTECH SPRING GREEN NITRILE POWDER FREE EXAM GLOVES (S)4343843438-532020-03-13
00036000434392KIMTECH SPRING GREEN NITRILE POWDER FREE EXAM GLOVES (M)4343943439-532020-03-13
00036000434408KIMTECH SPRING GREEN NITRILE POWDER FREE EXAM GLOVES (L)4344043440-532020-03-13
00036000434415KIMTECH SPRING GREEN NITRILE POWDER FREE EXAM GLOVES (XL)4344143441-532020-03-13
00036000434439KIMTECH FOREST GREEN NITRILE POWDER-FREE EXAM GLOVES (XS)4344343443-532020-03-13
00036000434446KIMTECH FOREST GREEN NITRILE POWDER-FREE EXAM GLOVES (S)4344443444-532020-03-13
00036000434453KIMTECH FOREST GREEN NITRILE POWDER-FREE EXAM GLOVES (M)4344543445-532020-03-13
00036000434460KIMTECH FOREST GREEN NITRILE POWDER-FREE EXAM GLOVES (L)4344643446-532020-03-13
00036000434477KIMTECH FOREST GREEN NITRILE POWDER-FREE EXAM GLOVES (XL)4344743447-532020-03-13
00036000434484KIMTECH FOREST GREEN NITRILE POWDER-FREE EXAM GLOVES (XXL)4344843448-532020-03-13
00036000628203KIMTECH SPECTRUM NITRILE POWDER FREE EXAM GLOVES (S)6282062820-002020-11-10
00036000628210KIMTECH SPECTRUM NITRILE POWDER FREE EXAM GLOVES (M)6282162821-002020-11-10
00036000628227KIMTECH SPECTRUM NITRILE POWDER FREE EXAM GLOVES (L)6282262822-002020-11-10
00036000628234KIMTECH SPECTRUM NITRILE POWDER FREE EXAM GLOVES (XL)6282362823-002020-11-10
00036003528197KIMTECH LAVENDER NITRILE EXAM GLOVES (L)5281952819-542020-03-13
00036004528189KIMTECH LAVENDER NITRILE EXAM GLOVES (M)5281852818-542020-03-13
00036005528171KIMTECH LAVENDER NITRILE EXAM GLOVES (S)5281752817-542020-03-13
00036006528200KIMTECH LAVENDER NITRILE EXAM GLOVES (XL)5282052820-542020-03-13
00036007528162KIMTECH LAVENDER NITRILE EXAM GLOVES (XS)5281652816-542020-03-13

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Primary DI, Brand, Company table
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00840456214633JMUJMU DENTAL, INCFXX2026-07-07
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