Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010436932

FEI Number

3010436932

Entity Name

ANSELL SEREMBAN SDN. BHD

City/State/Country

Seremban Negeri Sembilan, MY

Establishment Address

Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, Seremban Negeri Sembilan 70450, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANSELL HEALTHCARE PRODUCTS LLC (Owner Number: 8020065)

Owner / Operator Contact Address

2301 Robb Drive, Reno, NV 89523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213289

PMA Number

N/A

All Registered Proprietary Names

LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein) Supreno SE SU-690 POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored) Micro-Touch Royal Blue Cobalt ® N19X GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS

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	2023-05-25
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-07-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-10-27
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-10-27
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2022-03-14
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-06-24
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-12-14
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-03-17
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2022-03-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-03-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-05-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-06-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-06-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2020-01-13
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-05-30
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-05-30
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-05-30

Official Correspondent

Don Cronk

US Agent Details

Don Cronk Business: ANSELL HEALTHCARE PRODUCTS LLC Email: don.cronk@ansell.com Phone: (775) 4707106

Related Public Records

Same Entity

ANSELL HEALTHCARE PRODUCTS LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3010459874	Ansell Perry de Mexico S.A. de C.V.	Cd. Juarez Chihuahua, MX
3009964047	ANSELL HEALTHCARE PRODUCTS LLC	Iselin, NJ, US
3003199637	Ansell Canada Inc.	Cowansville Quebec, CA
3004125670	Ansell Sandel Medical Solutions LLC	CHATSWORTH, CA, US

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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1000266564	SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.	Hat Yai Songkhla, TH
8040653	ARISTA LATINDO INDUSTRIAL, LTD. P.T.	JAKARTA BARAT, ID
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 3010436932. Last updated year: 2026. Please use registration number 3010436932 when referencing this establishment in official correspondence.