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
08859798108526SKYN088597981085262026-04-30
08859798108533SKYN088597981085332026-04-30
08859798108540SKYN088597981085402026-04-30
08859798108632SKYN088597981086322026-04-30
08859798108724SKYN088597981087242026-04-30
08859798108465SKYN088597981084652026-03-12
08859798108472SKYN088597981084722026-03-12
08859798108496SKYN088597981084962026-03-12
18859798108462SKYN088597981084652026-03-12
18859798108479SKYN088597981084722026-03-12
18859798108493SKYN088597981084962026-03-12
08859798108090LIFESTYLES088597981080902026-01-27
18859798108097LIFESTYLES088597981080902026-01-27
08859798108441SKYN088597981084412026-01-27
08859798108069SKYN088597981080692026-01-13
08859798108076LIFESTYLES088597981080762026-01-13
08859798108083LIFESTYLES088597981080832026-01-13
18859798108066SKYN088597981080692026-01-13
18859798108073LIFESTYLES088597981080762026-01-13
18859798108080LIFESTYLES088597981080832026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00302340996136Durex IntenseRECKITT BENCKISER LLCMOL2026-03-02
00302340995825Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340995993Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340996006Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340996013Durex Intense Ultra LubeRECKITT BENCKISER LLCMOL2025-09-01
00302340996020Durex Intense Ultra LubeRECKITT BENCKISER LLCMOL2025-09-01
00302340096584DUREX Intense Sensation CondomRECKITT BENCKISER LLCHIS2025-05-14
00302340300452DUREX Classic CondomRECKITT BENCKISER LLCHIS2025-05-14
00302340995696DUREX® Adventure PackRECKITT BENCKISER LLCHIS2025-03-20
00302340300421DUREX® Pleasure PackRECKITT BENCKISER LLCHIS2025-03-20
00302340989336DUREX® Pleasure PackRECKITT BENCKISER LLCHIS2025-03-20
00067981087970DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00067981087987DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00067981087994DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00302340090001DUREX Tropical CondomsRECKITT BENCKISER LLCHIS2025-03-13