PT. MEDISAFE TECHNOLOGIES

FDA Device Registration & Listing · Kab. Deli Serdang Sumatera Utara, ID · Registration 9616501

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
9616501
FEI Number
3002955419
Entity Name
PT. MEDISAFE TECHNOLOGIES
City/State/Country
Kab. Deli Serdang Sumatera Utara, ID
Establishment Address
Jl. Batang Kuis Gg. Tambak Rejo / PSR IX, Desa/Kelurahan Buntu Badimbar, Kec.Tanjung Morawa, Kab. Deli Serdang Sumatera Utara 20362, ID
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PT. MEDISAFE TECHNOLOGIES (Owner Number: 9019595)
Owner / Operator Contact Address
Jl. Batang Kuis Gg. Tambak Rejo / PSR IX, Desa Buntu Bedimbar, Tanjung Morawa, Medan, ID-SU 20362, ID
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K022765
PMA Number
N/A

All Registered Proprietary Names

Latex Examination Gloves Powderfree Polyisoprene Surgical Gloves Latex Examination Gloves Sterile Polychloroprene Examination Sterile Synthetic Rubber Exam Glove Latex Examination gloves Polychloroprene Powder-Free Surgical Glove Tested For Use With Chemotherapy Drugs-White & Green.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-03-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-10-11
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-10-11
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-10-11
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-10-11
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2023-10-11
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-10-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-10-11
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2023-10-11
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-06-12
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-06-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-07-08
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-11-26
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-11-26
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2016-01-12
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-01-12
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-11-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2011-11-08
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2011-11-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-03-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-04-07
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2010-12-20
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-06-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-06-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-03-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-03-06
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-04-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-04-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-01-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2008-12-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-12-12
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-06-24
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-01-12
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2016-01-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-07-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2007-12-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-05-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-05-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-11-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-11-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-12-16

Official Correspondent

Peggy Supratman

US Agent Details

Blix Winston Business: ACMD Consulting, LLC Email: fblixwinston@aol.com Phone: (301) 6079185

Related Public Records

Same Entity

PT. MEDISAFE TECHNOLOGIES
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
K002933 Maxxim Medical STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES 2000-10-19
K913402 Smith & Nephew Perry PERRY(R) DERMAGUARD(R) PLUS GLOVES 1991-10-02
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616501. Last updated year: 2026. Please use registration number 9616501 when referencing this establishment in official correspondence.
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