FDA.reportPublic FDA data

KIMTECH

Primary DI
10076490711426
Brand
KIMTECH
Company
Ansell Healthcare Product
Model
50602
Catalog number
50602
Device description
KIMTECH PURPLE NITRILE-XTRA (S) POWDER-FREE EXAM GLOVES
Published
2025-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113423000
K200633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113423000KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVEKimberly-Clark Corp.2012-03-09LZA
K200633000Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove0 & M Halyard, Inc.2020-10-11LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20076490724171PackageGS110In Commercial Distribution
10076490711426PrimaryGS10
00076490724016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007649072417120076490724171
1007649071142610076490711426
00076490724016000764907240160764907240160076490724016

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
775-470-7106don.cronk@ansell.com
775-746-6600nick.magri@ansell.com

Regulatory Flags#

DUNS number
111267330
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00769799205019MICROFLEXEV-2050-XSEV-2050-XS2022-03-17
00769799205026MICROFLEXEV-2050-SEV-2050-S2022-03-17
00769799205033MICROFLEXEV-2050-MEV-2050-M2022-03-17
00769799205040MICROFLEXEV-2050-LEV-2050-L2022-03-17
00769799205057MICROFLEXEV-2050-XLEV-2050-XL2022-03-17
10076490788657MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
10076490788664MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
10076490788671MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
10076490788688MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
10076490788695MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
20076490793160MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
20076490793177MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
20076490793184MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
20076490793191MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
20076490793207MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
10076490456525TOUCHNTUFF69318070693180702025-07-30
10076490456532TOUCHNTUFF69318080693180802025-07-30
10076490456549TOUCHNTUFF69318090693180902025-07-30
10076490456556TOUCHNTUFF69318100693181002025-07-30
10076490456518TOUCHNTUFF69318060693180602025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.QDO2026-06-04