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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 K211899
Device Name Surgical Face Mask
Applicant
Hubei Yi-Ya Protective Products Co., Ltd.
Miandong Rd., Hefeng Village, Xiliuhe Town, Xiantao City,
Xiantao,  CN
Applicant Contact Moody Shaw
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/21/2021
Decision Date 10/04/2021
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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