Primed Shoe Covers, Primed Head Covers

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K971076 ↗

FDA Product Code

FXP

Device Class

Class I

Regulation

21 CFR Part 878.4040

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

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

  Class II

  FDA 510(k) K021864 Active Cleared 23 Sep 2002

• Procedure Masks: PM4-301 and PM4-304

  Class II

  FDA 510(k) K011789 Active Cleared 22 Jun 2001

See all devices from Primeline Medical Products, Inc. →