FDA.reportPublic FDA data

Dental Grip ® Powder-Free

Primary DI
20813172025245
Brand
Dental Grip ® Powder-Free
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
390-0040
Device description
Gloves, Exam, Nitrile, Non-Sterile, Powder Free, Textured, Thinfilm, XL
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
LCCApplicator, Ocular Pressure
LZAPolymer Patient Examination Glove
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCCApplicator, Ocular PressureOphthalmic2
LZAPolymer Patient Examination GloveGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813172025262PackageGS110In Commercial Distribution
20813172025245PrimaryGS10
00813172025272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081317202526210813172025262
2081317202524520813172025245
00813172025272008131720252728131720252720813172025272

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
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813172023848NitriDerm® CS1161002026-10-09
10813172023855NitriDerm® CS1162002026-10-09
10813172023862NitriDerm® CS1163002026-10-09
10813172023879NitriDerm® CS1163502026-10-09
10813172024203NitriDerm®1352702022-12-08
10813172024210NitriDerm®1352752022-12-08
10813172024227NitriDerm®1352802022-12-08
10813172024234NitriDerm®1352852022-12-08
10813172024241NitriDerm®1352902022-12-08
00813172024183NitriDerm®1352602022-12-08
10813172024197NitriDerm®1352652022-12-08
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

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Primary DI, Brand, Company table
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