FDA.reportPublic FDA data

FAMA Male Latex Condoms

Primary DI
06936296700086
Brand
FAMA Male Latex Condoms
Company
Shanghai Personage Hygiene Products Co.,Ltd.
Model
53mm,Condom(Dotted)
Device description
Condom
Published
2024-07-26
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
16936296700083PackageGS13Not in Commercial Distribution
26936296700080PackageGS190Not in Commercial Distribution
06936296700086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693629670008316936296700083
2693629670008026936296700080
06936296700086069362967000866936296700086

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
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
06936296746992Male Latex Condoms53mm,condom(Plain,Ribbed,Dotted)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
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
06936296700017FAMA Male Latex Condoms53mm,Condom (Plain)2024-05-24

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