510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252534Substantially Equivalent

Surgical Face Mask (Ear mount)

Zhejiang Hangkang Medical Equipment Co., Ltd., Yiwu, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K252534 is the FDA 510(k) clearance record for Surgical Face Mask (Ear mount), a class II device, cleared for Zhejiang Hangkang Medical Equipment Co., Ltd. on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Zhejiang Hangkang Medical Equipment Co., Ltd. As of , FDA records show no recalls naming K252534.

Clearance record

Decision date
Received
(203 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Zhejiang Hangkang Medical Equipment Co., Ltd. 4th Floor, Production Bldg. 2, # 633-1,, Yiwu, CN
510(k) summary
Statement
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