IP Products

Primary DI
00860009907652
Brand
IP Products
Company
IP Products
Model
IPNGK-804
Catalog number
IPNGK-804
Device description
Glove PF Nitrile Exam Black X-Large 10/100
Published
2023-03-20
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
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009907690PackageGS110In Commercial Distribution
00860009907652PrimaryGS10
00860010093733Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009907690008600099076908600099076900860009907690
00860009907652008600099076528600099076520860009907652
00860010093733008600100937338600100937330860010093733

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
151890902
Device count
100
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
00860010093740IP ProductsIPNGK-805IPNGK-8052023-06-19
00860009907621IP ProductsIPNGK-801 IPNGK-801 2023-03-20
00860009907638IP ProductsIPNGK-802IPNGK-802 2023-03-20
00860009907645IP ProductsIPNGK-803IPNGK-8032023-03-20
00860009907669IP ProductsIPNGK-801 IPNGK-801 2023-03-20
00860010093719IP ProductsIPNGK-802IPNGK-802 2023-03-20
00860010093726IP ProductsIPNGK-803IPNGK-8032023-03-20
00860010093733IP ProductsIPNGK-804IPNGK-8042023-03-20
00860009119802IP ProductsIPNGB-701IPNGB-7012023-02-08
00860009119888IP ProductsIPNGB-701IPNGB-7012023-02-08
00860009119819IP ProductsIPNGB-702IPNGB-7022023-02-08
00860009119826IP ProductsIPNGB-703IPNGB-7032023-02-08
00860009119833IP ProductsIPNGB-704IPNGB-7042023-02-08

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Primary DI, Brand, Company table
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