Iindaba zeShishini

Imaski ye-FDA

2020-04-08
Imigangatho ye-FDA yemaski yaseMelika kunye neemfuno zokuqinisekiswa
Iimfuno zokuqinisekiswa kweMelika ze-FDA zeemaski ezikhuselweyo ngokubanzi:
NgokweCandelo lonyango lwe-FDA lase-US, inkqubo yile:
'Zalisa ifom yesicelo kwaye uqinisekise ulwazi;
“Fumana iKhowudi yePIN kwaye ubhatale umrhumo wonyaka;
Ndikhuphe inombolo yobhaliso;
Ukukhuphela iimveliso kumazwe angaphandle.
Iimfuneko zokufumana isiqinisekiso sokuhlanjwa kwangoko kwezamayeza:
Ngokwesiqinisekiso sonyango sase-US FDA sika-II, inkqubo yile:
â 'Uvavanyo lweemveliso (uvavanyo lwentsebenzo, uvavanyo lwebhayoloji); e68a84e799bee5baa631333433623735
Ukulungiselela amaxwebhu angama-510K kwaye ungenise kwi-FDA ukuze iphinde ihlolwe;
I-FDA ikhuphe ileta yokuvunywa eyi-510K;
Ukubhaliswa kwefekthri okugqibeleleyo kunye nokudweliswa koomatshini;
Ukukhuphela iimveliso ngaphandle.
Ugqirha wase-U.S. N95 nangaphezulu.
Ngokomgangatho wokuqinisekiswa kwe-NIOSH, amashishini kufuneka athumele iisampuli kwelebhu ye-NIOSH yokuvavanywa, kwaye angenise ulwazi lobuchwephesha (kubandakanya ulwazi lwenxalenye yenkqubo) kuhlolo lwexwebhu lwe-NIOSH. Emva kokuphononongwa kovavanyo novavanyo kudlulile, i-NIOSH ivuma kwaye ikhuphe ukuvunywa.

Ngaphambili:

Mask CE

Okulandelayo:

Imaski ekhuselayo