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Grand Work Plastic Products Co., Ltd.

China · Shijiazhuang Hebei · www.hongray.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000023986

This company has registrations in European Union, United States, United Kingdom, Canada, 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

pendingnot queried

EUEuropean UnionEUDAMED

27UDI-DI device records

Class I 27

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 16 registration records and 19 510(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

0registered imported devices

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

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

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 Union254 raw hits, 227 excluded, 27 confirmed

United States16 registration records, 19 510(k), 0 PMA, 3 excluded

United Kingdom1 confirmed, 5 excluded

Brazil0 confirmed, 3 excluded

Manufacturer names merged into this page: GRAND WORK PLASTIC PRODUCTS CO., LTD. · GRAND WORK PLASTIC PRODUCTS CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000023986
EU authorised representative: Lotus NL B.V.
UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

62004

12005

12006

22010

12014

52022

32023

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06973951581987	Nitrile Examination Gloves	Class I
EU	06973951581659	Sterile Nitrile Examination Gloves, Accelerator Free	Class I
EU	06973951581642	Sterile Nitrile Examination Gloves, Accelerator Free	Class I
EU	06973951581635	Sterile Nitrile Examination Gloves, Accelerator Free	Class I
UK	56286	Sterile Nitrile Examination Gloves	Class I
US	K232444	Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs	2023-12-20
US	K232039	Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	2023-08-09
US	K230217	Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs	2023-05-13

Grand Work Plastic Products Co., Ltd.

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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