FDA.reportPublic FDA data

Prudence Chocolate

Primary DI
10812420030027
Brand
Prudence Chocolate
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
K041837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041837000INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTEDInnolatex Sdn. Bhd2004-09-24HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812420030027PrimaryGS10
00812420030068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081242003002710812420030027
00812420030068008124200300688124200300680812420030068

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.

Regulatory Flags#

DUNS number
814851960
Device count
12
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
20812420030031Prudence ClassicCondom 2018-06-20
20812420030048Prudence SensitiveCondom 2018-06-20
10812420030003Prudence StrawberryCondom 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
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
19556807570843GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570867GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107277LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107284LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107291LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107383LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798104993PhillySURETEX LIMITED - BRANCHHIS2025-07-30
08859798105914LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106744LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106461LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-19
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106447LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106454LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106478LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106485LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106553LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106560LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08906007135351SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135399SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135436SKORE Thin Condoms with FlavorsTTK HEALTHCARE LIMITEDHIS2025-01-31