Primagard Surgical Gowns

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K023117 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306

  Class II

  FDA 510(k) K001951 Active Cleared 8 Sep 2000

• Primagard Surgical Gowns

  Class II

  FDA 510(k) K023266 Active Cleared 8 Nov 2002

• Primagard Yellow Surgical Mask, Pleated, Tie-on, PM4-307; Primagard Yellow Surgical Mask, Pleated, Ear-Loop, PM4-308; Prm

  Class II

  FDA 510(k) K021076 Active Cleared 16 Apr 2002

• Primed Prime-Plus Cotton Gauze Sponges

  Unclassified

  FDA 510(k) K971075 Active Cleared 22 Jun 1997

• Primed Shoe Covers, Primed Head Covers

  Class I

  FDA 510(k) K971076 Active Cleared 13 Jan 1998

• Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)

  Class II

  FDA 510(k) K021864 Active Cleared 23 Sep 2002

See all devices from Primeline Medical Products, Inc. →

• Are Primagard Surgical Gowns sterile when supplied, and what does this mean for their use in the operating room?

  No, Primagard Surgical Gowns are supplied in a non-sterile form. This means they are not pre-sterilized by the manufacturer and must be sterilized by the facility before use. Sterilization is typically performed using methods like autoclaving or ethylene oxide treatment, ensuring they meet surgical-grade sterility standards for use in the operating room.

• Can Primagard Surgical Gowns be reused, or are they intended for single-use only?

  Primagard Surgical Gowns are explicitly intended for single-use in operating room settings. Reuse is not recommended or supported by the manufacturer, as this could compromise barrier protection and increase the risk of contamination for both personnel and patients.

• What types of protection do Primagard Surgical Gowns provide during surgical procedures?

  These gowns are designed to create a barrier against microorganisms, body fluids, and particulate matter, helping to maintain a sterile field during surgery. They shield both surgical personnel and patients from potential contamination, which is critical for infection control in the operating room.

• How are Primagard Surgical Gowns regulated, and what does this mean for their use in clinical settings?

  Primagard Surgical Gowns are regulated under the FDA’s 510(k) clearance process (K023117) and fall under the classification for surgical gowns (21 CFR 878.4970). The clearance indicates they are deemed substantially equivalent to a legally marketed predicate device, meaning they meet established safety and effectiveness standards for use in surgical environments.