FDA.reportPublic FDA data

Prestige® Orthopaedic

Primary DI
10813172022377
Brand
Prestige® Orthopaedic
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
131750
Device description
Gloves, Surgical, Latex, Powder-Free, Textured, Bisque Finish, 7.5
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20813172022374PackageGS14In Commercial Distribution
10813172022377PrimaryGS10
00813172022370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081317202237420813172022374
1081317202237710813172022377
00813172022370008131720223708131720223700813172022370

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
802020693
Device count
25
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10813172025491NitriDerm® Biodegradable1792022025-12-22
10813172025507NitriDerm® Biodegradable1793022025-12-22
10813172025514NitriDerm® Biodegradable1793522025-12-22
20813172025474NitriDerm® Biodegradable1790522025-12-22

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