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PRIMUS GLOVES PVT LIMITED

India · Cochin Kerala · www.primusgloves.com

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, Israel, Russia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

4listed device types

Class I 4Class II 0Class III 0

plus 13 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 Union3 raw hits, 3 excluded, 0 confirmed

United States13 registration records, 7 510(k), 0 PMA, 11 excluded

United Kingdom0 confirmed, 1 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: PRIMUS GLOVES PRIVATE LTD. · PRIMUS GLOVES PRIVATE LIMITED · Primus Gloves Private Limited

Business registration

Legal name: PRIMUS GLOVES PRIVATE LIMITED
LEI: 335800TUGCVTM3AJT577
Registration status: Active
Legal form: Private Limited Company (Pvt Ltd)
Incorporated: 1997-12-31
Registered address: PLOT 14 A COCHIN SPECIAL ECONOMIC ZONE KAKKANAD ERNAKULAM, ERNAKULAM, 682037
Registration authority: Companies Register, no. U25191KL1998PTC011988
Registry record updated: 2025-10-23

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22002 · K021065

22003 · K030445

12016 · K143477

22017 · K170612

FDA listed device types

Vinyl Patient Examination Glove 1Polymer Patient Examination Glove 1Surgeon'S Gloves 1Latex Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170612	STERILE VINYL EXAMINATION GLOVES, Powder Free	2017-10-23
US	K170515	Sterile Nitrile Surgical Gloves, Powder-free	2017-06-09
US	K143477	Nitrile Patient Examination gloves, Powderfree, Blue color	2016-04-14
SA	ME0000018225SFDAA00002	Non-sterile latex chemotherapy examination gloves, powder free	—

PRIMUS GLOVES PVT LIMITED

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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