510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893522Substantially Equivalent

Surgeon's Gloves

Thai Fuji Latex Co., Ltd., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893522 is the FDA 510(k) clearance record for SURGEON'S GLOVES, a class II device, cleared for Thai Fuji Latex Co., Ltd. on under FDA product code FGO (Dislodger, Stone, Flexible). FDA records list one 510(k) clearance for Thai Fuji Latex Co., Ltd. As of , FDA records show no recalls naming K893522.

Clearance record

Decision date
Received
(259 days to decision)
Product code
FGO Dislodger, Stone, Flexible
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Thai Fuji Latex Co., Ltd. 650 California St., San Francisco CA
Third party review
No

Clearances, product code FGO

Trailing 12 months

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

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