FDA.reportPublic FDA data

NitriDerm® Ultra Black

Primary DI
20813172021797
Brand
NitriDerm® Ultra Black
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
187450
Device description
Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Chemo, Textured, Black, XXXL
Published
2022-12-08
Public version status
Update
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
LZCPatient Examination Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813172021790PackageGS110In Commercial Distribution
20813172021797PrimaryGS10
00813172021793Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081317202179010813172021790
2081317202179720813172021797
00813172021793008131720217938131720217930813172021793

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
802020693
Device count
90
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20813172021735NitriDerm® Ultra Black1870502022-12-08
20813172021742NitriDerm® Ultra Black1871002022-12-08
20813172021759NitriDerm® Ultra Black1872002022-12-08
20813172021766NitriDerm® Ultra Black1873002022-12-08
20813172021773NitriDerm® Ultra Black1873502022-12-08
20813172021780NitriDerm® Ultra Black1874002022-12-08
10813172025477NitriDerm® Biodegradable1790522025-12-22
10813172025484NitriDerm® Biodegradable1791022025-12-22
10813172025491NitriDerm® Biodegradable1792022025-12-22
10813172025507NitriDerm® Biodegradable1793022025-12-22
10813172025514NitriDerm® Biodegradable1793522025-12-22
20813172025474NitriDerm® Biodegradable1790522025-12-22
20813172025481NitriDerm® Biodegradable1791022025-12-22
20813172025498NitriDerm® Biodegradable1792022025-12-22
20813172025504NitriDerm® Biodegradable1793022025-12-22
20813172025511NitriDerm® Biodegradable1793522025-12-22
10813172025422NitriDerm® 1001640502025-11-12
10813172025439NitriDerm® 1001641002025-11-12
10813172025446NitriDerm® 1001642002025-11-12
10813172025453NitriDerm® 1001643002025-11-12

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