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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212273
Device Name Cross Protection ResQ300 Plus Surgical Face Mask
Applicant
Cross Protection (M) Sdn Bhd
11, Jln Perindustrian5, Jln Meru
Klang,  MY 41050
Applicant Contact Grace Tan
Correspondent
Cross Protection (M) Sdn Bhd
11, Jln Perindustrian5, Jln Meru
Klang,  MY 41050
Correspondent Contact Grace Tan
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/20/2021
Decision Date 08/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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