FDA.reportPublic FDA data

NitriDerm®

Primary DI
10813172024234
Brand
NitriDerm®
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
135285
Device description
Gloves, Surgical, Nitrile, Chemo, Powder-Free, Textured, 8.5
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20813172024231PackageGS14In Commercial Distribution
10813172024234PrimaryGS10
00813172024237Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081317202423120813172024231
1081317202423410813172024234
00813172024237008131720242378131720242370813172024237

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813172024203NitriDerm®1352702022-12-08
10813172024210NitriDerm®1352752022-12-08
10813172024227NitriDerm®1352802022-12-08
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
20813172025481NitriDerm® Biodegradable1791022025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417212MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417229MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417236MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417243MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417250MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
00199536000018BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195038CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14