Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025303965

FEI Number

3025303965

Entity Name

PT. SINTONG UNIGOLDEN GLOVE

City/State/Country

KISARAN Sumatera Utara, ID

Establishment Address

JL. LINTAS SUMATERA, HESSA PERLOMPONGAN, KEC. AIR BATU, KAB. ASAHAN, SUMATERA UTARA,, KISARAN Sumatera Utara 21272, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT. SINTONG UNIGOLDEN GLOVE (Owner Number: 10086606)

Owner / Operator Contact Address

JL. LINTAS SUMATERA, KEL. HESSA PERLOMPONGAN,, KEC. AIR BATU, KAB. ASAHAN, SUMATERA UTARA,, KISARAN, ID-SU 21272, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223235

PMA Number

N/A

All Registered Proprietary Names

Nitrile Examination Glove Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) biodegradable powder free nitrile examination glove, blue and green colors, low dermatitis potential, tested for use with chemotherapy drugs, fentanyl citrate, simulated gastric acid and fentanyl citrate-simulated gastric acid solution biodegradable powder free nitrile examination glove, low dermatitis,potential claim, blue, green, black, white, orange, black-white, teal-gray, white-green, white-orange, white-blue, blue-white, green-white, orange-white colors Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)

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	2025-05-20
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-05-20
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-05-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-05-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-25
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-25
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-11-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-11-23

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

PT. SINTONG UNIGOLDEN GLOVE

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

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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 3025303965. Last updated year: 2026. Please use registration number 3025303965 when referencing this establishment in official correspondence.