FDA.reportPublic FDA data

LIFESTYLES

Primary DI
08859798101558
Brand
LIFESTYLES
Company
SURETEX LIMITED - BRANCH
Model
08859798101558
Device description
LIFESTYLES PLEASURE COLLECTION 36CT (ULTRA SENSITIVE, CLOSER CONNECTION, ULTRA RIBBED, FLAVORS & COLORS) + 3 Naturally Endless Sachet 5ml
Published
2024-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000408000
K213921000
K221243000
K941258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000408000LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOMSuretex Prophylactics , Ltd.2000-04-19HIS
K213921000Microthin Natural Rubber Latex CondomSuretex Limited2022-04-28HIS
K221243000OFNat Lubricant (L15)Suretex Limited2022-09-30NUC
K941258000LATEX CONDOMSuretex, Ltd.1995-12-06HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859798101558PrimaryGS10
18859798101555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859798101558088597981015588859798101558
1885979810155518859798101555

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.

Contacts#

Phone, Email table
PhoneEmail
8482293224alexandra.kirkland@lifestyles.com

Regulatory Flags#

DUNS number
672044515
Device count
36
Kit
true
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

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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.NUC2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00796494006160Williams-Trading/Cloud 9 Water-Based 4ozCC Wellness LLCNUC2026-06-02
00796494006177Williams-Trading/Cloud 9 Water-Based 8ozCC Wellness LLCNUC2026-06-02
00796494006184Williams-Trading/Cloud 9 Cum Lubricant 8ozCC Wellness LLCNUC2026-06-02
00796494404089JO Cumplay 4ozCC Wellness LLCNUC2026-06-02
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
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00087701190797good neighbor pharmacyAmerisourcebergen Drug CorporationNUC2026-06-01
00787651760643AZOi-Health, Inc.NUC2026-05-29
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13