510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963504Substantially Equivalent

Medline Open End Finger Control Mitt

Medline, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963504 is the FDA 510(k) clearance record for MEDLINE OPEN END FINGER CONTROL MITT, a class I device, cleared for Medline on under FDA product code FMQ (Restraint, Protective). FDA records list 11 510(k) clearances for Medline, from to . As of , FDA records show no recalls naming K963504.

Clearance record

Decision date
Received
(56 days to decision)
Product code
FMQ Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Applicant
Medline One Medline Pl., Mundelein IL
510(k) summary
Summary
Third party review
No

Clearances, product code FMQ

Trailing 12 months

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

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