Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007829481

FEI Number

3007829481

Entity Name

INNOLATEX (THAILAND) LIMITED

City/State/Country

Hat Yai Songkhla, TH

Establishment Address

Lot E1-6 Export Processing Zone, Southern Industrial Estate, Village 4, Chalung, Hat Yai Songkhla 90110, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INNOLATEX SDN. BHD (Owner Number: 9042429)

Owner / Operator Contact Address

LOT 591 & 594, PERSIARAN RAJA LUMU,, PANDAMARAN INDUSTRIAL ESTATE,, PORT KLANG, MY-10 42000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

myONE Perfect Fit CVS CVS Walgreen One Vanish

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-10
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-02-03
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2026-01-13
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-09-09
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2022-12-12
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-09-09
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2026-05-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-08
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2025-05-07
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-08-03
MSC	Barrier, Std, Oral Sex	Obstetrics/Gynecology	Class 2	884.5300	2026-01-15
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-06-10
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-07-08
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2020-01-27
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2011-02-04
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2022-12-12

Official Correspondent

GOH MIAH KIAT

US Agent Details

DAVIN WEDEL Email: davin@globalprotection.com Phone: (617) 9462800

Related Public Records

Same Entity

INNOLATEX SDN. BHD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9616515	INNOLATEX SDN. BHD	PORT KLANG Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

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3006799339	Nulatex Sdn. Bhd.	Kluang Johor, MY
3026885377	SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD.	Shanghai, CN
9616559	RICHTER RUBBER TECHNOLOGY SDN. BHD.	KUALA KETIL Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007829481. Last updated year: 2026. Please use registration number 3007829481 when referencing this establishment in official correspondence.