510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K201991Substantially Equivalent

Medical surgical mask

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

K201991 is the FDA 510(k) clearance record for Medical surgical mask, a class II device, cleared for Shenzhen Everwin Precision Technology Co., Ltd. on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Shenzhen Everwin Precision Technology Co., Ltd. As of , FDA records show no recalls naming K201991.

Clearance record

Decision date
Received
(129 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shenzhen Everwin Precision Technology Co., Ltd. Block A&B&C, Ncbc Industrial Park, 6th Baolong Rd.,, 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