FDA.reportPublic FDA data

SKORE Thin Condoms with Flavors

Primary DI
08906007135481
Brand
SKORE Thin Condoms with Flavors
Company
TTK HEALTHCARE LIMITED
Model
SKORE NOTHING Chocolate
Device description
The SKORE Thin Condoms with Flavors - SKORE NOTHING Chocolate condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, Chocolate 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 Thin Condoms with flavors - SKORE NOTHING Chocolate natural rubber latex 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
Rx
false
OTC
true
Sterile
false
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
08906007135481PackageGS13In Commercial Distribution
08906007135498PackageGS1240In Commercial Distribution
08906007135504PackageGS12160In Commercial Distribution
08906007135474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906007135481089060071354818906007135481
08906007135498089060071354988906007135498
08906007135504089060071355048906007135504
08906007135474089060071354748906007135474

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+914442008231kalaivani.b@ttkhealthcare.com

Regulatory Flags#

DUNS number
675476406
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
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
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