510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971191Substantially Equivalent

Far-East Shoe Covers

Far East Science & Technology Development Co., Ltd., Garden Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971191 is the FDA 510(k) clearance record for FAR-EAST SHOE COVERS, a class I device, cleared for Far East Science & Technology Development Co., Ltd. on under FDA product code FXP (Cover, Shoe, Operating-Room). FDA records list 3 510(k) clearances for Far East Science & Technology Development Co., Ltd., from to . As of , FDA records show no recalls naming K971191.

Clearance record

Decision date
Received
(101 days to decision)
Product code
FXP Cover, Shoe, Operating-Room
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Far East Science & Technology Development Co., Ltd. 11250 Dale St. #59, Garden Grove CA
510(k) summary
Statement
Third party review
No

Clearances, product code FXP

Trailing 12 months

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

FDA records show no clearances under product code FXP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXP, 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