PT BASIC INTERNATIONAL SUMATERA

FDA Device Registration & Listing · Simalungun Regency Sumatera Utara, ID · Registration 3038284237

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038284237
FEI Number
3038284237
Entity Name
PT BASIC INTERNATIONAL SUMATERA
City/State/Country
Simalungun Regency Sumatera Utara, ID
Establishment Address
Surfactant Road, Land Parcels D9 - D16, C8 - C15, C16 (half) - C24, Sei Mangkei Economic Zone, Sei Mangkei Village / Sub - District, Bosar Maligas District,, Simalungun Regency Sumatera Utara 21183, ID
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PT BASIC INTERNATIONAL SUMATERA (Owner Number: 10093302)
Owner / Operator Contact Address
Surfactant Road, Land Parcels D9 -D16,C8-C15, C16 (Half) -C24, Sei Mangkei Economic Zone, Sei Mangkei Village /Sub -District, Bosar Maligas District,, Simalungun Regency, ID-SU 21183, ID
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250193
PMA Number
N/A

All Registered Proprietary Names

Disposable Nitrile gloves Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs pink Nitrile Powder-Free Exam 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, Simulated Gastric

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 2026-03-02
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-12-17
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-12-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-17
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-04-26
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-04-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-04-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-04-26
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 2025-11-20

Official Correspondent

Aditya Pratama

US Agent Details

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

Related Public Records

Same Entity

PT BASIC INTERNATIONAL SUMATERA
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038284237. Last updated year: 2026. Please use registration number 3038284237 when referencing this establishment in official correspondence.
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