Suretex L T D

FDA Filings

This page includes the latest FDA filings for Suretex L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8040641
• FEI Number: 3002808272
• Name: SURETEX, LTD.
• Owner & Operator: SURETEX, LTD.
• Contact Address: 31/1 Moo4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai; Phunphin TH-84 Surat Thani 84130 TH
• US Agent:
  • ALEXANDRA KIRKLAND
  • SXWELL USA LLC
  • 334 7142915
  • alexandra.kirkland@lifestyles.com
• Importing Logistics Registration:
  • Importer: ANSELL HEALTHCARE PRODUCTS LLC
  • Address: 111 WOOD AVENUE SOUTH SUITE 210 ; Iselin, NJ 08830 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 31/1 Moo4, Surattani-Thakuapha Road Tambon Khao Hua Kwai; Amphur Phunphin Surat Thani, 84130 TH
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K221243 Suretex Limited	OFNat Lubricant (L15)	2022-09-30
PMN K213921 Suretex Limited	Microthin Natural Rubber Latex Condom	2022-04-28
PMN K182438 | MOL SURETEX, LTD.	Skyn Polyisoprene Condom - Intrigue	2018-12-07
PMN K182438 | MOL SURETEX, LTD.	Skyn Polyisoprene Condom - 5 Senses	2018-12-07
PMN K172473 | NUC SURETEX, LTD.	Lifestyles Intimate Moments	2018-05-16
PMN K931077 | HIS SURETEX, LTD.	Kamasutra Ultrathin Latex Condom	2017-12-14
PMN K122720 | NUC SURETEX, LTD.	Lifestyles Warm Lovin Personal Lubricant	2017-12-14
PMN K122477 | NUC SURETEX, LTD.	Skyn Maximum Performance Personal Lubricant	2017-12-14
PMN K122477 | NUC SURETEX, LTD.	Lifestyles Luxe Presmium Lubricant	2017-12-14
PMN K122477 | NUC SURETEX, LTD.	LifeStyles Liquid Personal Lubricant (Silicone) 4.5g Sachets	2017-12-14
PMN K122476 | NUC SURETEX, LTD.	Lifestyles Smooth 2-in-1 Massage and Lubricant	2017-12-14
PMN K122054 | NUC SURETEX, LTD.	Lifestyles Natural Personal Lubricant	2017-12-14
PMN K033076 | HIS SURETEX, LTD.	Skyn Natural Feeling Personal Lubricant	2017-12-14
PMN K033076 | HIS SURETEX, LTD.	Lifestyles Liquid Personal Lubricant	2017-12-14
PMN K171172 | MOL SURETEX, LTD.	Skyn Cocktail	2017-08-04
PMN K171172 | MOL SURETEX, LTD.	SKYN PINA COLADA	2017-08-04
PMN K171172 | MOL SURETEX, LTD.	SKYN PASSION DAIQUIRI	2017-08-04
PMN K171172 | MOL SURETEX, LTD.	SKYN CHERRY SUNRISE	2017-08-04
PMN K160399 | MOL SURETEX, LTD.	SKYN	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN ORIGINAL	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN LARGE	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN EXTRA STUDDED	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN EXTRA LUBRICATED	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN ELITE	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN ELITE LARGE	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	SKYN ELITE EXTRA LUBRICATED	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	LIFESTYLES NON-LATEX PI STRIPS	2017-03-07
PMN K160399 | MOL SURETEX, LTD.	LIFESTYLES NATURAL LATEX FREE CONDOMS	2017-03-07
PMN K163107 | HIS SURETEX, LTD.	ULTRA SENSITIVE PLATINUM	2017-01-30
PMN K163107 | HIS SURETEX, LTD.	Lifestyles Zero	2017-01-30
PMN K992081 | HIS SURETEX, LTD.	Lifestyles, Contempo	2008-03-27
PMN K992081 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K992081 | HIS SURETEX, LTD.	LS TUXEDO	2008-03-27
PMN K983518 | HIS SURETEX, LTD.	NATURAL FEELING	2008-03-27
PMN K983518 | HIS SURETEX, LTD.	Lifestyles	2008-03-27
PMN K983518 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K942858 | HIS SURETEX, LTD.	LifeStyles	2008-03-27
PMN K942858 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K942858 | HIS SURETEX, LTD.	LS SPL, LS LUBRICATED W SPL, LS ULTRA LUB W SPL	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	ULTRA THIN, ULTRA THYN	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	ULTRA SENSITIVE	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	SNUGGER FIT	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	ROUGH RIDER STUDDED, ROUGH RIDER	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	PHILLY RIBBED, CUSTOM PHILLY, PHILLY X LARGE	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LifeStyle, Contempo	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	Latex condom	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES ULTRA LUBE PLUS	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES PLEASURE RIBBED, LIFESTYLES RIBBED	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES NON LUBRICATED, LIFESTYLES ULTRA SENSITIVE NON-LUBRICATED	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES LUBRICATED	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES HIS & HERS	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES EXTRA STRENGTH	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	LIFESTYLES ASSORTED COLOURS, LS ASST COLORS	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	Arouse, Bareback,EROTICA,Evening Magic,HARD RIDER ,ID PREMIUM,Kimono Colors,Lucky Boy,Momentos	2008-03-27
PMN K941258 | HIS SURETEX, LTD.	ADAM & EVE ULTRA THIN, ADAM & EVE HARD RIDER, ADAM & EVE RIBBED	2008-03-27
PMN K070800 | MOL SURETEX, LTD.	Polyisoprene Condom	2008-03-27
PMN K070800 | MOL SURETEX, LTD.	Lifestyles	2008-03-27
PMN K030176 | HIS SURETEX, LTD.	Marathon	2008-03-27
PMN K030176 | HIS SURETEX, LTD.	LifeStyle	2008-03-27
PMN K030176 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K010371 | LTZ SURETEX, LTD.	Lifestyles, RR Hot Passion	2008-03-27
PMN K010371 | LTZ SURETEX, LTD.	Latex Condom	2008-03-27
PMN K010371 | LTZ SURETEX, LTD.	HOT RIDER	2008-03-27
PMN K010371 | HIS SURETEX, LTD.	Lifestyles, RR Hot Passion	2008-03-27
PMN K010371 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K010371 | HIS SURETEX, LTD.	HOT RIDER	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	NYC KYNG CONDOM	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	MEGA RIDER	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	Lifestyles, Contempo	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	Latex Condom	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	LIFESTYLES LARGE CONDOM	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	KYNG GOLD	2008-03-27
PMN K001883 | LTZ SURETEX, LTD.	KING GOLD	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	NYC KYNG CONDOM	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	MEGA RIDER	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	Lifestyles, Contempo	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	LIFESTYLES LARGE CONDOM	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	KYNG GOLD	2008-03-27
PMN K001883 | HIS SURETEX, LTD.	KING GOLD	2008-03-27
PMN K000408 | HIS SURETEX, LTD.	Lifestyles, Contempo	2008-03-27
PMN K000408 | HIS SURETEX, LTD.	Latex Condom	2008-03-27
PMN K000408 | HIS SURETEX, LTD.	LS ULTRA STUDDED	2008-03-27
PMN K000408 | HIS SURETEX, LTD.	LIFESTYLES ASSORTED FLAVOURS, LS ASST FLAVORS	2008-03-27
PMN K030176 SURETEX, LTD.	LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT	2003-04-17
PMN K010371 SURETEX, LTD.	LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT	2001-04-27
PMN K941258 SURETEX, LTD.	LATEX CONDOM	1995-12-06
PMN K942858 SURETEX, LTD.	LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)	1995-05-18
PMN K910284 SURETEX, LTD.	CONDOMS (RUBBER CONTRACEPTIVES)	1991-06-04

Similar & Related FDA Registered Companies

• SURETEX PROPHYLACTICS (INDIA) PRIVATE LIMITED
• SURETEX PROPHYLACTICS LTD.
• SURETEX PROPHYLACTICS (INDIA) LTD.
• SURETEX LIMITED - BRANCH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092816017	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	1018 CTN
2020092813464	Laem Chabang,Thailand -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	400 CTN
2020092614740	Singapore,Singapore -> New York, New York	NATURAL LATEX CONDOM	794 CTN
202009214964	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	927 CTN
202009199521	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	927 CTN
202009148615	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	890 CTN
2020091446027	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	819 CTN
202009148616	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	NATURAL LATEX CONDOM	400 CTN