510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K210785Substantially Equivalent

Disposable Surgical Gowns

Chongqing Litai Fashion Group Limited Company, Chongqing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210785 is the FDA 510(k) clearance record for Disposable Surgical Gowns, a class II device, cleared for Chongqing Litai Fashion Group Limited Company on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list one 510(k) clearance for Chongqing Litai Fashion Group Limited Company. As of , FDA records show no recalls naming K210785.

Clearance record

Decision date
Received
(242 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Chongqing Litai Fashion Group Limited Company Bldg. D7-1, Chongqing China Textile & Garment City, Chongqing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYC

Trailing 12 months

FDA records hold no clearances under product code FYC in the trailing twelve months.

FDA records show no clearances under product code FYC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260