FDA.reportPublic FDA data

Lelo Hex Lubricated Natural Rubber Latex Condom 12’s

Primary DI
08852961029802
Brand
Lelo Hex Lubricated Natural Rubber Latex Condom 12’s
Company
Leloi AB
Model
12s
Device description
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243421000Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.2025-03-07HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08852961029802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08852961029802088529610298028852961029802

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

Regulatory Flags#

DUNS number
508701849
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
08852961033205Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 pack3 Pack2026-06-25
08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 pack12 pack2026-06-25
07350075023453LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK34532022-05-27
07350075024085HEX Condoms Original 36 Pack (US_TNR) 40852022-06-27
07350075024993LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK49932022-05-26
07350075029578HEX Condoms Original 72 Pack (US_TNR) 95782023-07-10
07350075022470HEX Condoms Original 3 Pack (US_TNR)24722016-09-23
07350075022494HEX Condoms Original 12 Pack (US_TNR)24972016-09-23
07350075024979HEX Condoms Respect 3 Pack (US_FR_TNR) Euroslot49792017-02-09
07350075025006HEX Condoms Respect 12 Pack (US_TNR)50062017-02-09
07350075025020HEX Condoms Respect 36 Pack (US_TNR)50202017-02-09
07350075028557Intimina Ziggy Cup 2 - Size B85572022-05-26
07350075028601Intimina Ziggy Cup 2 - Size A86012022-05-26
07350022276093Intimina Lily Cup Size A - EN60932016-09-21
07350022276109Intimina Lily Cup Size B - EN61092016-09-21
07350022276116Intimina Lily Cup Compact size A - EN61162016-09-21
07350075020117Intimina Lily Cup Compact size B - EN01172016-09-21
07350075020308Intimina Lily Cup Compact Tamaño A - ES03082016-09-21
07350075026065Intimina Lily Cup One60652017-11-07
07350075026140Intimina Ziggy Cup61402017-11-07

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
06925634004290RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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00726893120730One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
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00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
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00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
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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