Data / Medical devices / Thailand / Innolatex (thailand) Limited

Innolatex (thailand) Limited: FDA-registered device maker in Hat Yai Songkhla, Thailand, 8 510(k) clearances

Name: Innolatex (thailand) Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Innolatex (thailand) Limited is registered with the FDA (registration 3007829481) in Hat Yai Songkhla, Thailand. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 12, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007829481
Address: Lot E1-6 Export Processing Zone, Southern Industrial Estate Village 4, Chalung, Hat Yai Songkhla, Thailand, 90110
Owner or operator: INNOLATEX SDN. BHD (9042429)
Roles: Contract manufacturer, Manufacturer
First device listed: February 4, 2011
Registered through: 2026
Brand names listed: CVS, One Vanish, Walgreen, myONE Perfect Fit

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Std, Oral Sex	MSC	2	Contract manufacturer	accessdata.fda.gov
Condom	HIS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Condom, Synthetic	MOL	2	Contract manufacturer	accessdata.fda.gov
Lubricant, Personal	NUC	2	Contract manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 12, 2010	K092586	MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU	HIS	Substantially Equivalent	Innolatex (Thailand) Limited	accessdata.fda.gov
August 19, 1999	K991892	TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR	HIS	Substantially Equivalent	Line One Laboratories	accessdata.fda.gov
March 21, 1997	K970633	TUSTEX FLAVORED CONDOMS	HIS	Substantially Equivalent	Line One Laboratories	accessdata.fda.gov
February 14, 1997	K964599	TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR	HIS	Substantially Equivalent	Line One Laboratories	accessdata.fda.gov
February 14, 1997	K964598	TRUSTEX COLA FLAVORD CONDOM	HIS	Substantially Equivalent	Line One Laboratories	accessdata.fda.gov
February 13, 1997	K964591	TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR	HIS	Substantially Equivalent	Line One Laboratories	accessdata.fda.gov
July 15, 1996	K946103	TRUSTEX FLAVOR CONDON IN COLORS	HIS	Substantially Equivalent	Line One Laboratories & Trading Co.	accessdata.fda.gov
December 6, 1995	K944786	RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)	HIS	Substantially Equivalent	Line One Laboratories & Trading Co.	accessdata.fda.gov

Compare with other makers

Updated May 12, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.