FDA.reportPublic FDA data

KIMTECH BLUE NITRILE EXAM GLOVES (XS)

Primary DI
00036000505740
Brand
KIMTECH BLUE NITRILE EXAM GLOVES (XS)
Company
KIMBERLY-CLARK GLOBAL SALES, LLC
Model
50574
Catalog number
50574-53
Device description
Examination Gloves
Published
2020-03-13
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
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163267000NITRILE EXAMINATION GLOVEBrightway Holdings Sdn. Bhd.2017-03-24LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036000505747PackageGS110In Commercial Distribution
00036000505740PrimaryGS10
90036000505743Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600050574710036000505747
00036000505740000360005057400360005057400036000505740
9003600050574390036000505743

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from sources of light and radiation; Protect from moisture.
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)346-4652info@kcprofessional.com

Regulatory Flags#

DUNS number
830997032
Device count
100
DM exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29