FDA.reportPublic FDA data

KIMTECH LAVENDER NITRILE EXAM GLOVES (XS)

Primary DI
00036007528162
Brand
KIMTECH LAVENDER NITRILE EXAM GLOVES (XS)
Company
KIMBERLY-CLARK GLOBAL SALES, LLC
Model
52816
Catalog number
52816-54
Device description
Examination Gloves
Published
2020-03-13
Public version status
Update
Distribution status
Not 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
K162146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162146000Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)Brightway Holdings Sdn. Bhd.2017-01-05LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036007528169PackageGS110Not in Commercial Distribution
00036007528162PrimaryGS10
90036007528165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600752816910036007528169
00036007528162000360075281620360075281620036007528162
9003600752816590036007528165

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
250
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
00036000434316KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (XS)4343143431-532020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08