FDA.report

SKYN

Primary DI
28859798107035
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
08859798107031
Device description
SKYN KING XXL 36ct
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MOLCondom, Synthetic

Product Code Classifications

CodeDeviceSpecialtyClass
MOLCondom, SyntheticObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K232470000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232470000Polyisoprene Extra Large CondomSuretex Limited2024-05-09MOL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08859798107031PrimaryGS10
28859798107035Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08859798107031088597981070318859798107031
2885979810703528859798107035

GMDN Terms

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

Regulatory Flags

DUNS number
672044515
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
18859798108462SKYN088597981084652026-03-12
18859798108479SKYN088597981084722026-03-12
18859798108493SKYN088597981084962026-03-12
18859798108097LIFESTYLES088597981080902026-01-27
08859798108441SKYN088597981084412026-01-27
18859798108066SKYN088597981080692026-01-13
18859798108073LIFESTYLES088597981080762026-01-13
18859798108080LIFESTYLES088597981080832026-01-13
18859798107885SKYN088597981078882025-12-16
18859798107892SKYN088597981078952025-12-16
18859798107946SKYN088597981079492025-12-16
18859798107960SKYN088597981079632025-12-16
18859798107977SKYN088597981079702025-12-16
28859798108025SKYN088597981080212025-12-16
18859798108035SKYN088597981080382025-12-16
28859798108049SKYN088597981080452025-12-16
28859798108056SKYN088597981080522025-12-16
18859798107878LIFESTYLES088597981078712025-12-03
28859798106977SKYN088597981069732025-09-04
18859798107267LIFESTYLES088597981072602025-09-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
18859798108462SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108479SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108493SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
50302340996131Durex IntenseRB Health (us) LLCMOL2026-03-02
08859798108441SKYNSURETEX LIMITED - BRANCHMOL2026-01-27
18859798108066SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
18859798107885SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107892SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107946SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107960SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107977SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
28859798108025SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798108035SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
28859798108049SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
28859798108056SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
00813356000064Lifestyles SKYN Elite 40 ct BowlPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONMOL2025-09-11
28859798106977SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
18859798107311SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
18859798107328SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
28859798107592SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
00302340995931Durex Intense XLRB Health (us) LLCMOL2025-09-01
50302340995998Durex Intense XLRB Health (us) LLCMOL2025-09-01
50302340996001Durex Intense XLRB Health (us) LLCMOL2025-09-01
50302340996018Durex Intense Ultra LubeRB Health (us) LLCMOL2025-09-01
50302340996025Durex Intense Ultra LubeRB Health (us) LLCMOL2025-09-01
08859798106584SKYNSURETEX LIMITED - BRANCHMOL2025-07-30
28859798106960SKYNSURETEX LIMITED - BRANCHMOL2025-07-30
18859798106987SKYNSURETEX LIMITED - BRANCHMOL2025-07-30
28859798106991SKYNSURETEX LIMITED - BRANCHMOL2025-07-30
28859798107011SKYNSURETEX LIMITED - BRANCHMOL2025-07-30