YTY INDUSTRY (MANJUNG) SDN. BHD.

FDA Device Registration & Listing · SITIAWAN Perak, MY · Registration 9613997

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
9613997
FEI Number
3002563423
Entity Name
YTY INDUSTRY (MANJUNG) SDN. BHD.
City/State/Country
SITIAWAN Perak, MY
Establishment Address
LOT 1422-1424, BATU 10 LEKIR, SITIAWAN Perak 32020, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
YTY INDUSTRY SDN BHD (Owner Number: 8041009)
Owner / Operator Contact Address
LOT 1422-1424, BATU 10 LEKIR, SITIAWAN,, MY-08 32020, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Purple 9.5 HandsOn EZ-Off EZDoff EZDoffy Critical Response CR911 Critical Response High Visibility Gloves BISM Critical Response Nitrile Exam Gloves CURAD Versatile CUR9311

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 2015-11-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-18
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-12-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-12-18
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-12-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-07-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2010-04-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-02-12
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2021-05-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-05-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-07-25
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-07-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-07-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-07-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-05-13
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-08-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-08-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-08-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-29
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-10-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-08-09
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-08-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-07-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-07-09
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-12-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-08-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-11-07
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-11-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2019-03-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-10-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-10-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-06-29
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2017-06-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-02-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-02-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-02-18
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2011-12-08
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2011-12-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-08
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2022-08-08
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-08-08
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-08-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-08-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-08-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2016-12-01
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-12-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-02-28

Official Correspondent

Punitha Samy

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

YTY INDUSTRY SDN BHD
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 9613997. Last updated year: 2026. Please use registration number 9613997 when referencing this establishment in official correspondence.
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