FDA.reportPublic FDA data

FAMA Male Latex Condoms

Primary DI
16936296700090
Brand
FAMA Male Latex Condoms
Company
Shanghai Personage Hygiene Products Co.,Ltd.
Model
53mm,Condom(Ribbed)
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
Rx
false
OTC
true
Sterile
false
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
16936296700090PackageGS13Not in Commercial Distribution
26936296700097PackageGS190Not in Commercial Distribution
06936296700093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693629670009016936296700090
2693629670009726936296700097
06936296700093069362967000936936296700093

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529430956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
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
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

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