FDA.reportPublic FDA data

Prudence Classic

Primary DI
20812420030031
Brand
Prudence Classic
Company
DKT de México, S.A. de C.V.
Model
Condom
Device description
Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.
Published
2018-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002393000NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. Bhd2000-12-19HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20812420030031PrimaryGS10
00812420030075Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081242003003120812420030031
00812420030075008124200300758124200300750812420030075

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
814851960
Device count
48
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812420030072PRUDENCE CLASSIC C/12Condom 2020-02-14
10812420030096PRUDENCE SENSITIVE C/12Condom 2020-02-14
00812420030228PRUDENCE CLASSIC C/12Condom 2020-02-14
00812420030211PRUDENCE SENSITIVE C/12Condom 2020-02-14
00812420030242PRUDENCE MIX C/3Condom 2020-02-14
00812420030181PRUDENCE BANANACondom 2020-01-21
00812420030259PRUDENCE MIX C/12Condom 2020-01-21
10812420030188PRUDENCE BANANACondom 2020-01-21
20812420030185PRUDENCE BANANACondom 2020-01-21
10812420030010Prudence MintCondom 2018-06-20
20812420030024Prudence ChocolateCondom 2018-06-20
20812420030000Prudence StrawberryCondom 2018-06-20
20812420030017Prudence MintCondom 2018-06-20
20812420030048Prudence SensitiveCondom 2018-06-20
10812420030003Prudence StrawberryCondom 2018-06-20
10812420030027Prudence ChocolateCondom 2018-06-20
10812420030034Prudence ClassicCondom 2018-06-20
10812420030041Prudence SensitiveCondom 2018-06-20
00812420030006Prudence StrawberryCondom 2018-06-20
00812420030013Prudence MintCondom 2018-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936296747371Male Latex CondomsShanghai Personage Hygiene Products Co.,Ltd.HIS2026-06-26
08852961033205Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-06-25
08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-06-25
08859798108960LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
08859798108977LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
06925634004245RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004252RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004269RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004276RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004290RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
00726893120365One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120730One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120747One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00810124865085Adam and Eve hard riderGLOBAL PROTECTION CORP.HIS2026-06-08
00860015576620Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
10860015576603Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03