510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K212869Substantially Equivalent

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

Fugou County Shenxiang Manufacturing Co., Ltd., Zhoukou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212869 is the FDA 510(k) clearance record for Disposable Surgical Gown, Disposable Reinforced Surgical Gown, a class II device, cleared for Fugou County Shenxiang Manufacturing Co., Ltd. on under FDA product code FYA (Gown, Surgical). FDA records list one 510(k) clearance for Fugou County Shenxiang Manufacturing Co., Ltd. As of , FDA records show no recalls naming K212869.

Clearance record

Decision date
Received
(95 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Fugou County Shenxiang Manufacturing Co., Ltd. Industrial Clusters,#2 Rd.,Fugou County, Zhoukou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260