FDA.reportPublic FDA data

Male Latex Condoms

Primary DI
06936296746992
Brand
Male Latex Condoms
Company
Shanghai Personage Hygiene Products Co.,Ltd.
Model
53mm,condom(Plain,Ribbed,Dotted)
Device description
Condom
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K220576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220576000FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd.2022-08-05HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936296746999PackageGS136In Commercial Distribution
26936296746996PackageGS172In Commercial Distribution
06936296746992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693629674699916936296746999
2693629674699626936296746996
06936296746992069362967469926936296746992

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Regulatory Flags#

DUNS number
529430956
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936296747371Male Latex Condoms53mm,condom(Plain,Ribbed,Dotted)2026-06-26
06936296747159Male Latex Condoms53mm,condom(Plain)2026-05-11
06936296747166Male Latex Condoms53mm,condom(Dotted)2026-05-11
06936296747173Male Latex Condoms53mm,condom(Ribbed)2026-05-11
06936296746985Male Latex Condoms53mm,condom(Plain)2026-04-01
06936296742512Male Latex Condoms53mm condom(Plain)2026-03-25
06936296742529Male Latex Condoms53mm condom(Dotted)2026-03-25
06936296742536Male Latex Condoms53mm condom(Ribbed)2026-03-25
06936296700055FAMA Male Latex Condoms53mm,Condom(Dotted)2024-07-26
06936296700062FAMA Male Latex Condoms53mm,Condom(Ribbed)2024-07-26
06936296700086FAMA Male Latex Condoms53mm,Condom(Dotted)2024-07-26
06936296700093FAMA Male Latex Condoms53mm,Condom(Ribbed)2024-07-26
06936296700109FAMA Male Latex Condoms53mm,Condom(Dotted)2024-07-26
06936296700116FAMA Male Latex Condoms53mm,Condom(Ribbed)2024-07-26
16936296700052FAMA Male Latex Condoms53mm,Condom(Dotted)2024-07-26
16936296700069FAMA Male Latex Condoms53mm,Condom(Ribbed)2024-07-26
16936296700083FAMA Male Latex Condoms53mm,Condom(Dotted)2024-07-26
16936296700090FAMA Male Latex Condoms53mm,Condom(Ribbed)2024-07-26
16936296700106FAMA Male Latex Condoms53mm,Condom(Dotted)2024-07-26
16936296700113FAMA Male Latex Condoms53mm,Condom(Ribbed)2024-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06977708239701ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239718ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239725ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239732ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
00860014891533HUNKHunk World, Inc.HIS2026-08-19
00860014891540HUNKHunk World, Inc.HIS2026-08-19
00860014891557HUNKHunk World, Inc.HIS2026-08-19
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08852961028935Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-07-22
08852961028942Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-07-22
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
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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
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