FDA.reportPublic FDA data

Smile Makers Come Connected

Primary DI
04897041441680
Brand
Smile Makers Come Connected
Company
Ramblin Brands USA LLC
Model
22.07.0018
Device description
10 Natural Rubber Latex Male Condoms
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897041441680PackageGS112In Commercial Distribution
04897041441697PackageGS120In Commercial Distribution
04897041441673PrimaryGS10
04897041442861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897041441680048970414416804897041441680
04897041441697048970414416974897041441697
04897041441673048970414416734897041441673
04897041442861048970414428614897041442861

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 away from direct sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118615221
Device count
10
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
true
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80028373140105WINK CLOSEROKAMOTO USA, INC.HIS2026-03-11
80028373149993WINK CLOSEROKAMOTO USA, INC.HIS2026-03-06
06925634004177AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004214AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004221AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004238AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
80860014891508HUNKGLOBAL PROTECTION CORP.HIS2026-02-23
80860014891515Hunk WorldGLOBAL PROTECTION CORP.HIS2026-02-23
00860015047229Condom SenseGLOBAL PROTECTION CORP.HIS2026-02-23
10860015047233Condom senseGLOBAL PROTECTION CORP.HIS2026-02-23
18859798108073LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
18859798108080LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
00860014772207DOGTAG CONDOMSSuzhou Colourway New Material Co., Ltd.HIS2025-12-17
00860014772214DOGTAG CONDOMSSuzhou Colourway New Material Co., Ltd.HIS2025-12-17
09556807501949XO!RICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-15
18859798107878LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
09556807500850GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
09556807500874GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
09556807500898GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
06977708230012ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230029ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230036ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230043ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
00813356005014Crown Lubricated 500 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005069Crown Lubricated 250 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005137Kimono Bowl Microthin 40 ct BowlPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005205Crown Lubricated 100 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005380Paradise Super Thin 100 CondomPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-09-05
18859798107267LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
18859798107274LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04