Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021641087

FEI Number

3021641087

Entity Name

DYNACARE SDN BHD

City/State/Country

Sitiawan Perak, MY

Establishment Address

Lot 15528 (PT5001), Kawasan Perusahaan Kampung Acheh, Sitiawan Perak 32000, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dynacare SDN BHD (Owner Number: 10084090)

Owner / Operator Contact Address

Lot 15528 (PT5001), Kawasan Perusahaan Kampung Acheh, Sitiawan, MY-08 32000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223221

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
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-06
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Dynacare 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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021641087. Last updated year: 2026. Please use registration number 3021641087 when referencing this establishment in official correspondence.