FDA.reportPublic FDA data

GETANE

Primary DI
06925634004153
Brand
GETANE
Company
Suzhou Colourway New Material Co., Ltd.
Model
Large size Orange flavor Male, large (55 ± 2mm) t
Published
2025-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K083817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083817000M. DIOR BRANDSuzhou Colour-Way Enterprise Development Co., Ltd.2009-09-16HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925634004153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925634004153069256340041536925634004153

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

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
06925634004290RogitarExtended Pleasure, medium(53±2mm) thickness: 0.0652026-06-10
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
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
06977708239688ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239695ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239701ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239718ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239725ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239732ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
00860014891533HUNKHunk World, Inc.HIS2026-08-19
00860014891540HUNKHunk World, Inc.HIS2026-08-19
00860014891557HUNKHunk World, Inc.HIS2026-08-19
08852961028959Lelo Hex Lubricated Natural Rubber Latex Condom 36’sLeloi ABHIS2026-07-27
08852961028935Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-07-22
08852961028942Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-07-22
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
06925634004290RogitarSuzhou 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