FDA.reportPublic FDA data

SKORE Smooth Condoms

Primary DI
08906007135870
Brand
SKORE Smooth Condoms
Company
TTK HEALTHCARE LIMITED
Model
SKORE Blues - Vanilla
Device description
The SKORE Smooth Condoms - SKORE Blues- Vanilla condom is made of natural rubber latex. It is straight walled, smooth, teat ended, blue colored, vanilla flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Smooth Condoms - SKORE Blues-Vanilla natural rubber latex male condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Published
2025-01-31
Public version status
New
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
K230049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230049000SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUTTtk Healthcare Limited2023-09-07HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906007135887PackageGS13In Commercial Distribution
08906007135894PackageGS1240In Commercial Distribution
08906007135900PackageGS12160In Commercial Distribution
08906007135870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906007135887089060071358878906007135887
08906007135894089060071358948906007135894
08906007135900089060071359008906007135900
08906007135870089060071358708906007135870

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.

Contacts#

Phone, Email table
PhoneEmail
+91444200234deepika.n@ttkhealthcare.com
+91444200831kalaivani.b@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
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
08906007135726SKORE Benzocaine CondomsSKORE NOT OUT Climax Delay2025-01-31

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