BETELCARE SDN BHD

FDA Device Registration & Listing · Kapar Selangor, MY · Registration 8040910

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
8040910
FEI Number
3366
Entity Name
BETELCARE SDN BHD
City/State/Country
Kapar Selangor, MY
Establishment Address
Lot 3342, Jalan Keretapi Lama,, 7 1/2, Off Jalan Kapar,, Kapar Selangor 42200, MY
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BETELCARE SDN BHD (Owner Number: 10077738)
Owner / Operator Contact Address
Lot 3342, Jalan Keretapi Lama,, 7 1/2, Off Jalan Kapar,, Kapar, MY-10 42200, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K073299
PMA Number
N/A

All Registered Proprietary Names

BETEL GLOVES

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 2020-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

BETELCARE 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 8040910. Last updated year: 2026. Please use registration number 8040910 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.