FDA.reportPublic FDA data

Kitchmart

Primary DI
09557621701584
Brand
Kitchmart
Company
Kitchmart Trading
Model
GNN.L100
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
09557621701676PackageGS110In Commercial Distribution
09557621701584PrimaryGS10
19557621701581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09557621701676095576217016769557621701676
09557621701584095576217015849557621701584
1955762170158119557621701581

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.

Sterilization Methods#

Method table
Method

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
09557621701591KitchmartGNN.XL1002023-02-12
08522650085944KitchmartGNN.M10B2023-02-12
08522650086002KitchmartGNN.L10B2023-02-12
08522650086170KitchmartGNN.XL10B2023-02-12
09557621701577KitchmartGNN.M1002023-02-12
09557621701683KitchmartGNN.XL1002023-02-12

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