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510(k) K233723

Medical surgical mask by Guangdong Kingfa Sci. & Tech.Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2024
Date Received
November 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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  • K211220 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (July 22, 2021)
  • K203593 — Patient Examination Gloves (March 19, 2021)

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