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SafeSource Direct Glove Plant

USA · Broussard
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 5Class II 1Class III 0
plus 6 registration records and 3 510(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
0active device licences
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 States6 registration records, 3 510(k), 0 PMA
Manufacturer names merged into this page: SAFESOURCE DIRECT · SafeSource Direct Glove Plant
Same-named companies — This database also contains companies with near-identical names: Safesource Direct, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Broussard

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

22022 · K222898
12025 · K250502

FDA listed device types

Cap, Surgical 1Non-Surgical Gown 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Cover, Shoe, Operating-Room 1Mask, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)2025-03-19
USK222898SafeSource Direct Blue Powder-Free Nitrile Exam Gloves2022-11-07
USK221134Procedure Mask with Ear Loops and Surgical Mask with Ties2022-05-19

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