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Professional Latex Sdn Bhd

Malaysia · Kamunting Perak · www.professionallatex.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN MY-MF-000009415

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Taiwan — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

12UDI-DI device records

Class I 12

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 10 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class I 1

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union251 raw hits, 239 excluded, 12 confirmed

United States10 registration records, 3 510(k), 0 PMA, 52 excluded

United Kingdom1 confirmed, 6 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia2 confirmed, 5 excluded

Canada0 confirmed, 10 excluded

Manufacturer names merged into this page: PROFESSIONAL LATEX SDN. BHD. · PROFESSIONAL LATEX SDN BHD · Professional Latex Sdn Bhd

Regulatory identity

EU manufacturer SRN: MY-MF-000009415
EU authorised representative: mdi Europa GmbH
UK responsible person: Nextec Medical UK Ltd

FDA 510(k) clearances by year

12017 · K171667

12018 · K173053

12023 · K220088

FDA listed device types

Fentanyl And Other Opioid Protection Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	19551012185042	Cenger Nitril Nitrile Powder Free Gloves	Class I
EU	09551012185045	Cenger Nitril Nitrile Powder Free Gloves	Class I
EU	19551012185035	Cenger Nitril Nitrile Powder Free Gloves	Class I
EU	09551012185038	Cenger Nitril Nitrile Powder Free Gloves	Class I
UK	56286	ProNitrile Nitrile Examination Gloves, Powder Free	Class I
US	K220088	Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	2023-03-30
US	K173053	POWDER FREE LATEX EXAMINATION GLOVE	2018-06-06
US	K171667	Powder Free Nitrile Examination Glove	2017-09-08
SA	ME0000000055SFDAA00004	ZAD	—
SA	ME0000000055SFDAA00004	ZAD	—

Professional Latex Sdn Bhd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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