Kitchmart

Primary DI
09557621701591
Brand
Kitchmart
Company
Kitchmart Trading
Model
GNN.XL100
Published
2023-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K112294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112294000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09557621701683PackageGS110In Commercial Distribution
09557621701591PrimaryGS10
19557621701598Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09557621701683095576217016839557621701683
09557621701591095576217015919557621701591
1955762170159819557621701598

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.

Regulatory Flags#

DUNS number
030905836
Device count
100
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852265008570KitchmartGNN.L10B2023-09-06
00852265008587KitchmartGNN.XL10B 2023-09-06
00852265008983KitchmartGNN.S10B2023-09-06
00852265008563KitchmartGNN.M10B2023-09-06
00852265008600KitchmartGNN.L10B2023-09-06
00852265008617KitchmartGNN.XL10B 2023-09-06
10852265008980KitchmartGNN.S10B2023-09-06
08522650085630KitchmartGNN.M10B2023-02-12
08522650085708KitchmartGNN.L10B2023-02-12
08522650085876KitchmartGNN.XL10B2023-02-12
08522650085944KitchmartGNN.M10B2023-02-12
08522650086002KitchmartGNN.L10B2023-02-12
08522650086170KitchmartGNN.XL10B2023-02-12
09557621701577KitchmartGNN.M1002023-02-12
09557621701584KitchmartGNN.L1002023-02-12
09557621701683KitchmartGNN.XL1002023-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
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