TEKMEDIC (M) SDN BHD

FDA Device Registration & Listing · MELAKA, MY · Registration 9681163

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
9681163
FEI Number
3005680067
Entity Name
TEKMEDIC (M) SDN BHD
City/State/Country
MELAKA, MY
Establishment Address
LOT 4, KAW.PERINDUSTRIAN TANJUNG KLING, TANJUNG BRUAS JETTY, MELAKA 76400, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TEKMEDIC (M) SDN BHD (Owner Number: 9010436)
Owner / Operator Contact Address
33A, LORONG RAHIM KAJAI 13, TAMAN TUN DR. ISMAIL, KUALA LUMPUR, MY-14 60000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K121591
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-11-20
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2012-12-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2013-02-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-02-04
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-11-20
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2008-12-15
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2007-11-20
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2010-12-22
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2012-12-26

Official Correspondent

RONALD LEONG

US Agent Details

JERRY LEONG Business: MEDGLUV INC. Email: jleong@medgluv.com Phone: (561) 2128885

Related Public Records

Same Entity

TEKMEDIC (M) 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
K894452 Kerala Rubber & Reclaims, Ltd. KRR GLOVE, PATIENT EXAMINATION GLOVES 1989-08-09
K891323 Li Wah-Hong Kong, Inc. LI WAH LATEX EXAMINATION GLOVES 1989-08-31
K891418 C & K Mfg. & Sales Co. LATEX EXAMINATION GLOVES, STYLE 510 LX 1989-06-22
K994255 Pt. Maja Agung Latexindo LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE 2000-02-07
K892946 Yeou-Fwu Rubber Industrial Co., Ltd. STERILE PATIENT EXAMINATION GLOVES 1989-08-10

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3002661124 ULINE, INC. Pleasant Prairie, WI, US
3019769825 HARTALEGA NGC SDN. BHD. (LOT 39496) Sepang Selangor, MY
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681163. Last updated year: 2026. Please use registration number 9681163 when referencing this establishment in official correspondence.
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