FDA.reportPublic FDA data

DermAssist®

Primary DI
20813172024583
Brand
DermAssist®
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
163200
Device description
Gloves, Exam, Vinyl, Non-Sterile, Powder-Free, Stretch, Blue, M
Published
2022-12-08
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
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813172024586PackageGS110In Commercial Distribution
20813172024583PrimaryGS10
00813172024589Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081317202458610813172024586
2081317202458320813172024583
00813172024589008131720245898131720245890813172024589

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
100
Premarket exempt
true
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
20813172021797NitriDerm® Ultra Black1874502022-12-08
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

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Primary DI, Brand, Company table
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10840330705230ProCureTwin Med, LLCLYZ2026-05-27
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
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10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19