Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040614

FEI Number

3002807146

Entity Name

HARTALEGA SDN BHD

City/State/Country

Bestari Jaya Selangor, MY

Establishment Address

No 7, Kawasan Perusahaan Suria, Bestari Jaya Selangor 45600, MY

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HARTALEGA SDN BHD (Owner Number: 8040614)

Owner / Operator Contact Address

C-G-9,Jalan Dataran SD1,Dataran SD PJU9, Bandar Sri Damansara, KUALA LUMPUR, MY-NOTA 52200, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201748

PMA Number

N/A

All Registered Proprietary Names

BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. Powderfree Nitrile Patient Examination Nitrile Powder Free Examination Glove (Blue) Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Mi POWDERED STERILE LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) BLUE POWDER FREE NITRILE EXAMINATION GLOVES Nitrile Powder Free Examination Glove (Aqua Blue) Nitrile Powder Free Examination Glove (Aqua Blue) - Extended Cuff Nitrile Powder Free Examination Glove (Orange) Nitrile Powder Free Examination Glove (Black) Nitrile Powder Free Examination Glove (Black) - Extended Cuff Nitrile Powder Free Examination Glove (Orange) - Extended Cuff GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (blue) CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT BLUE POWDER-FREE NITRILE EXAMINATION GLOVES PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Sterile Nitrile Powder Free Examination Gloves - Aqua Blue (ABLU) Sterile Nitrile Powder Free Examination Gloves - Violet Blue (VBLU) Nitrile Powder Free Examination Gloves Powder Free Latex Patient Examination Gloves NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES Shieldfive Chlorinated Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less) Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) POWDER FREE STERILE LATEX SURGICAL GLOVES NITRILE POWDERED EXAMINATION GLOVES (WHITE) Sante Premium Blue Nitrile Examination Gloves Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - VBLU Nitrile powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs - ABLU Blue Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs - CBLU Biodegradable Nitrile Powder Free Examination Glove (Blue) Nitrile PF Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES Powdered Latex Examination Glove with Protein Content Labeling Claim (200 micrograms or less) Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs -Dark Violet Blue (DVBU) Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs -Dark Blue (DKBU) Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White) Multiple Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove Polyisoprene Powder Free Surgical Underglove, Polyisoprene Powder Free Surgical Glove Nitrile Powder Free Eamination Gloves Tested for Use with Chemotherapy Drugs; White, Violet Blue, Aqua Blue and Violet Nitrile Powder Free Examination Glove with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs Patient Examination Gloves Latex Powder - Free Latex Examination Gloves Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) NITRILE POWDERED EXAMINATION GLOVES (BLUE) POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) Multiple Nitrile PF Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

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	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-12-21
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-06-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-12-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-07-10
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-08-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-02-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-05-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-08-06
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2020-08-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-08-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-06-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-07-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2009-10-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2009-10-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-08-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-01-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-06-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-07-20
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-03-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-03-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-01-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-27
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-09-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-06-01
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-06-01
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2018-02-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2012-07-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-01-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-04-28
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2015-04-28
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-12-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-12-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-12-12
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-09-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-09-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-10-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-10-20

Official Correspondent

KUAN KAM HON

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

HARTALEGA 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040614. Last updated year: 2026. Please use registration number 8040614 when referencing this establishment in official correspondence.