FDA.reportPublic FDA data

Rogitar

Primary DI
06925634004290
Brand
Rogitar
Company
Suzhou Colourway New Material Co., Ltd.
Model
Extended Pleasure, medium(53±2mm) thickness: 0.065
Published
2026-06-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222611000Male Latex CondomsSuzhou Colour-Way New Material Co., Ltd.2022-11-28HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925634004290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925634004290069256340042906925634004290

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.

Regulatory Flags#

DUNS number
544612070
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
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925634004245RogitarStrawberry Flavored, large (55±2mm) thickness: 0.02026-06-10
06925634004252RogitarChocolate Flavored, large (55±2mm) thickness: 0.062026-06-10
06925634004269RogitarCherry Flavored, large (55±2mm) thickness: 0.065 ±2026-06-10
06925634004276RogitarUltraThin, large (55±2mm) thickness: 0.045 ± 0.0152026-06-10
06925634004283RogitarHyaluronic Acid, large (55±2mm) thickness: 0.065 ±2026-06-10
06925634004177AowawoStrawberry flavor, large (55±2mm) thickness: 0.0652026-03-02
06925634004214AowawoStrawberry flavor, extra dotted, medium (53±2mm), 2026-03-02
06925634004221AowawoStrawberry flavor, Ribbed, medium (53±2mm), thick2026-03-02
06925634004238AowawoStrawberry flavor, Ultra-thin, medium (53±2mm), t2026-03-02
00860014772207DOGTAG CONDOMSRibbed, medium (53±2mm) thickness: 0.065 ± 0.015mm2025-12-17
00860014772214DOGTAG CONDOMSRibbed, medium (53±2mm) thickness: 0.065 ± 0.015mm2025-12-17
06925634004139GETANERibbed and Studded Condoms,medium(53 ± 2mm) thickn2025-10-24
06925634004146GETANE Large size Super smooth and moisturizing Male, la2025-10-24
06925634004153GETANE Large size Orange flavor Male, large (55 ± 2mm) t2025-10-24
06925634004160GETANE Large size Ultra-thin, large (55 ± 2mm) thickness2025-10-24
06925634004184JIAOYUEExtra Dotted Latex Male Condoms, medium (53±2mm) t2025-10-24
06925634004207GETANE Large size Strawberry flavor Male, large (55 ± 2m2025-10-24
06925634009011Aowawo3 in 1 Male Latex Condoms, medium (53 ± 2mm) thick2025-08-21
06925634004504GETANE Extra Dotted Condoms, medium (53 ± 2mm) thickness2025-06-10
06925634004511GETANELarge size Condoms, medium (55 ± 2mm) thickness: 02025-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936296747371Male Latex CondomsShanghai Personage Hygiene Products Co.,Ltd.HIS2026-06-26
08852961033205Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-06-25
08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-06-25
08859798108960LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
08859798108977LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
06925634004245RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004252RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004269RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004276RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
00726893120365One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120730One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120747One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00810124865085Adam and Eve hard riderGLOBAL PROTECTION CORP.HIS2026-06-08
00860015576620Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
10860015576603Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
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
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04