FDA.reportPublic FDA data

LIFESTYLES

Primary DI
00070907231227
Brand
LIFESTYLES
Company
SURETEX LIMITED - BRANCH
Model
3122
Device description
LIFESTYLES SENSUAL COLLECTION 12CT- CONTAINS ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM AND SKYN ELITE
Published
2020-08-26
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
MOLCondom, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2
MOLCondom, SyntheticObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160399000
K163107000
K941258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160399000Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC2016-07-25MOL
K163107000Lifestyles Zero Lubricated Latex Male CondomAnsell Healthcare Products, LLC2017-01-23HIS
K941258000LATEX CONDOMSuretex, Ltd.1995-12-06HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00070907231227PrimaryGS10
80070907000003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00070907231227000709072312270709072312270070907231227
8007090700000380070907000003

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, synthetic polymerA sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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
672044515
Device count
12
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
08859798109585SKYN088597981095852026-10-26
08859798109592LIFESTYLES088597981095922026-10-26
08859798109608SKYN088597981096082026-10-26
08859798109615SKYN088597981096152026-10-26
08859798109622SKYN088597981096222026-10-26
08859798109639SKYN088597981096392026-10-26
08859798109646SKYN088597981096462026-10-26
08859798109653SKYN088597981096532026-10-26
08859798109660SKYN088597981096602026-10-26
08859798108670SKYN088597981086702026-09-18
08859798108687SKYN088597981086872026-09-18
08859798108694SKYN088597981086942026-09-18
08859798108700SKYN088597981087002026-09-18
08859798108717SKYN088597981087172026-09-18
08859798100322LIFESTYLES088597981003222023-09-14
08859798100155SKYN088597981001552023-09-14
08859798100209SKYN088597981002092023-09-14
08859798100421SKYN088597981004212023-09-15
08859798100919SKYN088597981009192023-09-22
08859798101282SKYN088597981012822023-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859798109585SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109592LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-10-26
08859798109608SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109615SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109622SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109639SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109646SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109653SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109660SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
00028373060247004® ZERO ZERO FOUR® HydraSlide CONDOMSOKAMOTO USA, INC.HIS2026-10-21
00810124865115Adam and eve RibbedGLOBAL PROTECTION CORP.HIS2026-10-14
10022600830020Trojan Ultra Thin CondomCHURCH & DWIGHT CO., INC.HIS2026-10-07
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
08859798108953SKYNSURETEX LIMITED - BRANCHMOL2026-06-25
08859798108960LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
08859798108977LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25