510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K202358Substantially Equivalent

Protective Face Mask for Medical Use

Hunan Heng Chang Pharmaceutical Co., Ltd., Changsha, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202358 is the FDA 510(k) clearance record for Protective Face Mask for Medical Use, a class II device, cleared for Hunan Heng Chang Pharmaceutical Co., Ltd. on under FDA product code FXX (Mask, Surgical). FDA records list 2 510(k) clearances for Hunan Heng Chang Pharmaceutical Co., Ltd., from to . As of , FDA records show no recalls naming K202358.

Clearance record

Decision date
Received
(163 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hunan Heng Chang Pharmaceutical Co., Ltd. Floor 2,3, 102 Of Bldg. 16, Standard Plant Of Shanhe, Changsha, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FXX

Trailing 12 months
8 clearances under product code FXX in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
November 20251
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260