510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K250082Substantially Equivalent

Procedure mask/Surgical mask/Face mask

Winner Medical Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250082 is the FDA 510(k) clearance record for Procedure mask/Surgical mask/Face mask, a class II device, cleared for Winner Medical Co., Ltd. on under FDA product code FXX (Mask, Surgical). FDA records list 18 510(k) clearances for Winner Medical Co., Ltd., from to . As of , FDA records show no recalls naming K250082.

Clearance record

Decision date
Received
(156 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Winner Medical Co., Ltd. Winner Industrial Park, #660 Bulong Rd., Longhua District, Shenzhen, 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