Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043785

FEI Number

1000153953

Entity Name

LAGLOVE (M) SDN. BHD.

City/State/Country

KAJANG, Selangor, MY

Establishment Address

LOT 478, JALAN SIMPANG BALAK,, OFF BATU 13, JALAN CHERAS, KAJANG, Selangor 43000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LAGLOVE (M) SDN. BHD (Owner Number: 9003781)

Owner / Operator Contact Address

LOT 478, JALAN SIMPANG BALAK,, OFF BATU 13, JALAN CHERAS, KAJANG, SELANGOR, DARUL EHSAN, MY-NOTA 43000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mallory Safety And Supply LLC Bakner Manufacturing LLC Mallory Safety And Supply LLC Bakner Manufacturing LLC

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	2007-12-05
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-05

Official Correspondent

BASKARAN GOVINDASAMY

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

LAGLOVE (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

Similar Registrations

Registration Number	Establishment Name	Location
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
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 8043785. Last updated year: 2026. Please use registration number 8043785 when referencing this establishment in official correspondence.