FDA.reportPublic FDA data

Sustain Natural Extra Large Ribs and Dots.

Primary DI
08906007132084
Brand
Sustain Natural Extra Large Ribs and Dots.
Company
TTK HEALTHCARE LIMITED
Model
Sustain Natural Extra Large Ribs and Dots
Device description
The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bulbous teat ended, fully textured, transparentmale condom. it meets the requirements as specified in ASTM D3492 standard for rubber latex contraceptives (Male Condoms). TheSustain Natural Extra large Ribs and Dots natural rubber latex condoms are used for contraception and for prophylactic purposes (toHelp prevent pregnancy and the transmission of sexually transmitted diseases)
Published
2018-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132490000SKORE AND MULTIPLE BRANDSTtk Protective Devices Limited (Formerly Ttk-Lig L2014-10-20HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906007132091PackageGS13In Commercial Distribution
08906007132107PackageGS118In Commercial Distribution
08906007132114PackageGS1144In Commercial Distribution
08906007132121PackageGS110In Commercial Distribution
08906007132138PackageGS160In Commercial Distribution
08906007132145PackageGS1480In Commercial Distribution
08906007132152PackageGS1144In Commercial Distribution
08906007132169PackageGS11152In Commercial Distribution
08906007132084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906007132091089060071320918906007132091
08906007132107089060071321078906007132107
08906007132114089060071321148906007132114
08906007132121089060071321218906007132121
08906007132138089060071321388906007132138
08906007132145089060071321458906007132145
08906007132152089060071321528906007132152
08906007132169089060071321698906007132169
08906007132084089060071320848906007132084

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 condoms in a cool, dry place ( below 100deg.F). Avoid exposure to direct sunlight.

Contacts#

Phone, Email table
PhoneEmail
+914442008231info@ttkhealthcare.com

Regulatory Flags#

DUNS number
675476406
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
08906007135351SKORE Dotted CondomsSKORE Belgian Chocolate2025-01-31
08906007135399SKORE Dotted CondomsSKORE Dots - Vanilla2025-01-31
08906007135436SKORE Thin Condoms with FlavorsSKORE NOTHING Strawberry2025-01-31
08906007135474SKORE Thin Condoms with FlavorsSKORE NOTHING Chocolate2025-01-31
08906007135511SKORE Thin Condoms with FlavorsSKORE SKINTHIN2025-01-31
08906007135559SKORE Bulbous CondomsSKORE Warm2025-01-31
08906007135597SKORE Bulbous CondomsSKORE COOL2025-01-31
08906007135634SKORE Benzocaine CondomsSKORE NOTHING Climax Delay2025-01-31
08906007135672SKORE Benzocaine CondomsSKORE DUO MAX2025-01-31
08906007135719SKORE Benzocaine CondomsSKORE NOT OUT Climax Delay2025-01-31
08906007135870SKORE Smooth CondomsSKORE Blues - Vanilla2025-01-31
08906007135368SKORE Dotted CondomsSKORE Belgian Chocolate2025-01-31
08906007135405SKORE Dotted CondomsSKORE Dots - Vanilla2025-01-31
08906007135443SKORE Thin Condoms with FlavorsSKORE NOTHING Strawberry2025-01-31
08906007135481SKORE Thin Condoms with FlavorsSKORE NOTHING Chocolate2025-01-31
08906007135528SKORE Thin Condoms with FlavorsSKORE SKINTHIN2025-01-31
08906007135566SKORE Bulbous CondomsSKORE Warm2025-01-31
08906007135603SKORE Bulbous CondomsSKORE COOL2025-01-31
08906007135641SKORE Benzocaine CondomsSKORE NOTHING Climax Delay2025-01-31
08906007135689SKORE Benzocaine CondomsSKORE DUO MAX2025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
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