Primagard Surgical Equipment Drapes

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

510(k) Number

K022868 ↗

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. →

• What is the intended use of Primagard Surgical Equipment Drapes?

  These drapes are designed to serve as a protective barrier for surgical equipment. They are used during surgical procedures to shield devices from contamination or damage by providing a covering made from a blend of natural and synthetic materials.

• Are these drapes supplied in a sterile condition?

  No, Primagard Surgical Equipment Drapes are supplied as non-sterile products. They are intended to be used as a protective covering for equipment in a surgical environment, and users should follow their facility's protocols for handling non-sterile items in the operating room.

• What is the regulatory status of this device?

  Primagard Surgical Equipment Drapes are regulated under FDA 510(k) clearance K022868. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the same product category.