Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008604557

FEI Number

3008604557

Entity Name

STGT Surat Thani

City/State/Country

Phlai Wat , Kanchanadit Surat Thani, TH

Establishment Address

189 Moo 7, Phlai Wat , Kanchanadit Surat Thani 84160, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. (Owner Number: 8041108)

Owner / Operator Contact Address

110 Kanjanavanit Road, Pahtong, Hat Yai, TH-90 90230, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200539

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-04-09
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2020-04-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-04-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-08-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-11-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-11-13
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-09-04
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-09-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-09-04
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-09-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-11-13
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2020-11-13
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

Richard Ractliffe Business: Sri Trang USA, Inc. Email: richard.ractliffe@sritrangusa.com Phone: (312) 5153274

Related Public Records

Same Entity

SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020160813	STGT-TG 1	Kantang Trang, TH
3021206556	STGT ANV	Sadao Songkhla, TH
3006979699	VANDA GLOVE	Pahtong, Hat Yai Songkhla, TH
3021206557	STGT CP	Pathio Chumphon, TH
3019849096	STGT PS1	Sadao Songkhla, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3042765418	VITAL EDGE INSTRUMENTS LLC	Leesburg, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008604557. Last updated year: 2026. Please use registration number 3008604557 when referencing this establishment in official correspondence.