510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944054Substantially Equivalent

Powder Free Surgeon's Glove

Arent Fox, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944054 is the FDA 510(k) clearance record for POWDER FREE SURGEON'S GLOVE, a class II device, cleared for Arent Fox on under FDA product code KGD (Scissors For Cystoscope). FDA records list 4 510(k) clearances for Arent Fox, from to . As of , FDA records show no recalls naming K944054.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KGD Scissors For Cystoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Arent Fox 1050 Connecticut Ave., NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code KGD

Trailing 12 months

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

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