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
K905109Substantially Equivalent

Patient Examination Glove/hypoallergenic

Tactyl Technologies, Inc., Vista CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905109 is the FDA 510(k) clearance record for PATIENT EXAMINATION GLOVE/HYPOALLERGENIC, a class I device, cleared for Tactyl Technologies, Inc. on under FDA product code FMC (Patient Examination Glove). FDA records list 7 510(k) clearances for Tactyl Technologies, Inc., from to . As of , FDA records show no recalls naming K905109.

Clearance record

Decision date
Received
(8 days to decision)
Product code
FMC Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Tactyl Technologies, Inc. 2595 Commerce Way, Vista CA
Third party review
No

Clearances, product code FMC

Trailing 12 months

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

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