Matrix Dri-Idea (Plastic Dispos. Surgical Gown)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K850177 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Matrx Medical Maximizer 1000 and 2000 Vacuum Pump

  Class I

  FDA 510(k) K915353 Active Cleared 27 Dec 1991

• Mitraflex(Tm) Wound Dressing

  Class I

  FDA 510(k) K873277 Active Cleared 17 Sep 1987

• Nitronox(R), First Response Nitronox(Tm)

  Class II

  FDA 510(k) K883833 Active Cleared 17 Feb 1989

• Matrx Hope(R) 5 Resuscitator

  Class II

  FDA 510(k) K921982 Active Cleared 28 Oct 1994

• Matrx, Pyramid Triangle Bandage

  Class I

  FDA 510(k) K912661 Active Cleared 21 Aug 1991

• Centurion(Tm) Mixer

  Class II

  FDA 510(k) K884879 Active Cleared 9 Feb 1989

See all devices from Matrix Medica, Inc. →

• What is the Matrix Dri-Idea surgical gown used for?

  The Matrix Dri-Idea surgical gown is intended to provide protective barrier coverage during surgical procedures in general and plastic surgery settings, as stated in its description.

• Is the Matrix Dri-Idea gown sterile or non-sterile, and is it reusable?

  The Matrix Dri-Idea gown is supplied as a single-use, non-sterile device, meaning it is not sterilized before use and is designed for one-time use only, not for reuse.

• How is the Matrix Dri-Idea gown regulated and cleared for market?

  The Matrix Dri-Idea gown is regulated under FDA 510(k) clearance K850177 with product code FYA, and it was cleared through the traditional 510(k) pathway on February 21, 1985, as substantially equivalent to a predicate device.