FDA.reportPublic FDA data

Pulse® CR Pink

Primary DI
50813172023129
Brand
Pulse® CR Pink
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
193202
Device description
Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Pink, M
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OPCPowder-Free Polychloroprene Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPCPowder-Free Polychloroprene Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50813172023129PackageGS110In Commercial Distribution
40813172023122PrimaryGS10
00813172023124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081317202312950813172023129
4081317202312240813172023122
00813172023124008131720231248131720231240813172023124

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA device made of polychloroprene (neoprene) 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
802020693
Device count
200
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889813067994Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068007Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068021Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068038Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068045Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
D6620705854632Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
D6620705854630Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
10850002458173Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10850002458180Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10850002458197Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00371347010909Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00371347011258Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10371347011255Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00850002458176Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00850002458190Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
30813172023095Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
30813172023118Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
30813172023132Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023122Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023092Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023115Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
00813172023131Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
TQ26PC001Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC101Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC301Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC401Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC501Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP001Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP101Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP301Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06