Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040641

FEI Number

3002808272

Entity Name

SURETEX, LTD.

City/State/Country

Amphur Phunphin Surat Thani, TH

Establishment Address

31/1 Moo 4, Suratthani-Thakuapha Road, Tambon Khao Hua Kwai, Amphur Phunphin Surat Thani 84130, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SURETEX, LTD. (Owner Number: 9010022)

Owner / Operator Contact Address

31/1 Moo4, Suratthani-Thakuapha Road, Tambon Khao Hua Kwai, Phunphin, TH-84 84130, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171172

PMA Number

N/A

All Registered Proprietary Names

Marathon Benzocaine Condoms Adam & Eve - Marathon condoms hims Climax Delay Latex Condoms (clockstopper) Rider Everlast LIFESTYLES NATURAL PERSONAL LUBRICANT Lifestyles Smooth 2-in-1 Massage and Lubricant/LIFESTYLES SMOOTH 2-IN-1 SKYN NATURALLY ENDLESS LUBRICANT SKYN SUPREME FEEL SKYN SUPREME FEEL EXTRA LUBRICATED LIFESTYLES CLOSER CONNECTION Rider Midnight Black Condom BULK TESTED CONDOM BLACK 52 STRAIGHT SHAFT LIFESTYLES TUXEDO LIFESTYLES ASSORTED COLORS CONDOM HOTLINE BLACK HYGEIA COLORS CONDOM BLACK LS ASST COLORS CONDOM STPS 2S 1000 HOTLINE SKYN WARMING CONDOM SKYN EXCITATION LIFESTYLES LARGE LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE LIFESTYLES ULTRA SENSITIVE TITAN LIFESTYLES NYC KYNG MEGA RIDER LIFESTYLES KING GOLD/LIFESTYLES KYNG GOLD LIFESTYLES NYC LARGE SKYN KING XXL Polyisoprene Extra Large Condom SKYN XXL LIFESTYLES SENSATION MAX Lifestyles Warm Lovin Personal Lubricant SKYN SKYN COCKTAIL CLUB SKYN CHERRY SUNRISE SKYN PINA COLADA SKYN PASSION DAIQUIRI SKYN ELITE LARGE SKYN ORIGINAL SKYN ELITE LIFESTYLES NATURAL LATEX FREE SKYN EXTRA STUDDED SKYN ELITE EXTRA LUBE LIFESTYLES NON-LATEX PI SKYN SNUG FIT LIFESTYLES LARGE NON-LATEX SKYN KING ELITE LARGE EXTRA GLIDE SKYN LARGE SKYN KING SKYN SELECTION SKYN KING ULTRA THIN SKYN EXTRA LUBRICATED SKYN KING LARGE SKYN Snug Fit SKYN KING ELITE LARGE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-03-27
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2017-12-14
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2017-12-14
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2022-10-12
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2023-11-06
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2022-05-19
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-03-27
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2018-12-07
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-03-27
LTZ	Condom With Nonoxynol-9	Obstetrics/Gynecology	Class 2	884.5310	2008-03-27
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2025-01-20
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-01-20
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2023-10-23
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2017-12-14
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2017-03-07
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2017-08-04

Official Correspondent

SUTTHIDA CHAIYA

US Agent Details

ALEXANDRA KIRKLAND Business: SXWELL USA LLC Email: alexandra.kirkland@lifestyles.com Phone: (848) 2293224

Related Public Records

Same Entity

SURETEX, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040641. Last updated year: 2026. Please use registration number 8040641 when referencing this establishment in official correspondence.