FDA.reportPublic FDA data

SKYN

Primary DI
00792554902007
Brand
SKYN
Company
Lil' Drug Store Products, Inc.
Model
210100
Catalog number
90200
Device description
SKYN Original Non-Latex Condom,3ct
Published
2022-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K171172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171172000Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC2017-08-02MOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792554902007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792554902007007925549020077925549020070792554902007

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093103646
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792554999908Eroxon99990999902024-10-21
00079255499990Eroxon99990999902024-10-21
00792554902014SKYN210120902012022-09-12
00792554902021SKYN210124902022022-09-12
00792554903004Lifestyles832389903002022-09-12
00792554903028Lifestyles833042903022022-09-12
00792554903035Lifestyles832436903032022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00302340129008DUREX Extra Sensitive CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340241007DUREX Extra Sensitive CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340853279DUREX Performax Intense CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340853293DUREX Performax Intense CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340876421DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00302340876438DUREX Air Close Fit CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340876445DUREX Air Close Fit CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340876452DUREX Air Close Fit CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340876506DUREX Extra Sensitive Thin Close Fit CondomRECKITT BENCKISER LLCHIS2025-03-13
00302340894555DUREX Real Feel Non-Latex CondomRECKITT BENCKISER LLCMOL2025-03-13