Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038187455

FEI Number

3038187455

Entity Name

PT K-TECH INDUSTRIES

City/State/Country

Simalungun Sumatera Utara, ID

Establishment Address

Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab., Simalungun Sumatera Utara 21183, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT K-Tech Industries (Owner Number: 10093197)

Owner / Operator Contact Address

Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab., Simalungun, ID-SU 21183, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243792

PMA Number

N/A

All Registered Proprietary Names

Nitrile Powder-Free Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-11-20
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-11-20
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-11-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-11-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-04-13
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-04-13
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-04-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-04-13

Official Correspondent

Aditya Pratama

US Agent Details

Max Lee Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

PT K-Tech Industries

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
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038187455. Last updated year: 2026. Please use registration number 3038187455 when referencing this establishment in official correspondence.