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
K941336Substantially Equivalent

Combo Mask

Gam Industries, Inc., Petersburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941336 is the FDA 510(k) clearance record for COMBO MASK, a class I device, cleared for Gam Industries, Inc. on under FDA product code KGB (Mask, Oxygen, Non-Rebreathing). FDA records list 9 510(k) clearances for Gam Industries, Inc., from to . As of , FDA records show no recalls naming K941336.

Clearance record

Decision date
Received
(172 days to decision)
Product code
KGB Mask, Oxygen, Non-Rebreathing
Regulation
21 CFR 868.5570
Device class
Class I
Review panel
Anesthesiology
Applicant
Gam Industries, Inc. P.O. Box 2226, Petersburg VA
510(k) summary
Summary
Third party review
No

Clearances, product code KGB

Trailing 12 months

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

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