Sterilization Wrap Type 22, 44, 77

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

510(k) Number

K883376 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Towel Pack, Surgical

  Not classified

  FDA 510(k) K863733 Active Cleared 14 Oct 1986

• Sterile Pack (Procedural Tray/Kits)

  Class I

  FDA 510(k) K882275 Active Cleared 18 Jul 1988

• Nonwoven Surgical Drape Pack

  Class II

  FDA 510(k) K862062 Active Cleared 10 Jun 1986

• Medical, Disposable Bedding

  Class I

  FDA 510(k) K850067 Active Cleared 19 Apr 1985

• Pad, Pre-Operative Preparation

  Class I

  FDA 510(k) K850811 Active Cleared 21 Mar 1985

• Towel Pack, Surgical

  Not classified

  FDA 510(k) K850016 Active Cleared 23 Jan 1985

• What is the Sterilization Wrap Type 22 44 77 used for?

  It is intended to enclose another medical device that is to be sterilized by a health care provider, allowing sterilization of the enclosed device and maintaining its sterility until use.

• Is the Sterilization Wrap Type 22 44 77 sterile when supplied?

  No, the device is supplied as a non-sterile wrap, meaning it must undergo sterilization by the user before enclosing a medical device for processing.

• Can the Sterilization Wrap Type 22 44 77 be reused?

  Yes, the wrap is designed as a reusable device, allowing multiple cycles of use after proper cleaning and sterilization between uses.

• What regulatory authorization does the Sterilization Wrap Type 22 44 77 have?

  It is authorized under FDA 510(k) clearance K883376 and was determined to be substantially equivalent to a predicate device, classified under product code FRG.

• Who manufactures the Sterilization Wrap Type 22 44 77 and where are they located?

  The device is manufactured by East Texas Lighthouse For the Blind, located at 1716 Forest Ave., Tyler, TX 75702, United States.