Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616896

FEI Number

3003346215

Entity Name

FORMOSA GLOVE INDUSTRIAL CO., LTD.

City/State/Country

TAINAN, TW

Establishment Address

No. 251, Mayou 1st Rd., Madou Dist., TAINAN 721013, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FORMOSA GLOVE INDUSTRIAL CO., LTD. (Owner Number: 9034492)

Owner / Operator Contact Address

No. 251, Mayou 1st Rd., Madou Dist., --, TAINAN, TW-NOTA 721013, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992588

PMA Number

N/A

All Registered Proprietary Names

Nitrile Patient Examination Gloves, Nitrile Patient Examination Glove

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	2007-12-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-17

Official Correspondent

XIE RI MEI

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

FORMOSA GLOVE INDUSTRIAL CO., 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
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

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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 9616896. Last updated year: 2026. Please use registration number 9616896 when referencing this establishment in official correspondence.