HomeMalaysiaWEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II

WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II

Malaysia · Klang Selangor
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 44 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
5active device licences
Class II 5
TWTaiwanTFDA
pendingnot queried
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.

United States44 registration records, 15 510(k), 0 PMA, 8 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: WEAR SAFE (MALAYSIA) SDN. BHD. · WEAR SAFE (MALAYSIA) SDN BHD · WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
Same-named companies — This database also contains companies with near-identical names: WEAR SAFE (MALAYSIA) SDN. BHD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Klang Selangor

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11998
41999
12000
22006
32009
22010
12013
12017

FDA listed device types

Surgeon'S Gloves 1Fentanyl 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)

MarketIdentifierNameClass / date
USK172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim2017-09-29
USK123469POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE2013-02-19
USK101799POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE2010-09-03
CA91110STERILE LATEX EXAMINATION GLOVEClass II
CA91111STERILE LATEX SURGICAL GLOVEClass II
CA92951STERILE LATEX SURGICAL GLOVESClass II

Similar companies

AAMEDIX GLOVE SDN BHD
Malaysia · markets 3
Advanced Safety Lifecare Sdn. Bhd.
Malaysia · markets 0
Angel sports sdn.bhd
Malaysia · markets 1
ATL Products Tech Sdn Bhd
Malaysia · markets 0
CCB Medical Devices Sdn Bhd
Malaysia · markets 2
CONCH HYGIENE PRODUCTS SDN BHD
Malaysia · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →