FDA.reportPublic FDA data

KIMTECH STERLING NITRILE EXAM GLOVES (XL)

Primary DI
00036000507096
Brand
KIMTECH STERLING NITRILE EXAM GLOVES (XL)
Company
KIMBERLY-CLARK GLOBAL SALES, LLC
Model
50709
Catalog number
50709-54
Device description
Examination Gloves
Published
2020-03-23
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
LZCPatient examination glove, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161215000Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd.2016-12-21LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036000507093PackageGS110In Commercial Distribution
00036000507096PrimaryGS10
90036000507099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600050709310036000507093
00036000507096000360005070960360005070960036000507096
9003600050709990036000507099

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
170
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
10850061371246American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZC2026-11-02
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
10809160541470HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541487HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541494HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
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00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
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00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
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00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15