FDA.reportPublic FDA data

LIFESTYLES

Primary DI
08859798107383
Brand
LIFESTYLES
Company
SURETEX LIMITED - BRANCH
Model
08859798107383
Device description
LifeStyles Ultra Sensitive Latex Condom 1008 RP
Published
2025-09-04
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
K941258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941258000LATEX CONDOMSuretex, Ltd.1995-12-06HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859798107383PrimaryGS10
18859798107380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859798107383088597981073838859798107383
1885979810738018859798107380

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
672044515
Device count
1008
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
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
19556807570843GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570867GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107277LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107284LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107291LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798104993PhillySURETEX LIMITED - BRANCHHIS2025-07-30
08859798105914LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106744LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106461LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-19
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106447LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106454LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106478LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106485LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106553LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106560LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08906007135351SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135399SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135436SKORE Thin Condoms with FlavorsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135474SKORE Thin Condoms with FlavorsTTK HEALTHCARE LIMITEDHIS2025-01-31