Gauze, Sponges, Cat # 11-003

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983016 ↗

FDA Product Code

EFQ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Vitalcare Disposable Vaginal Speculum

  Class II

  FDA 510(k) K983716 Active Cleared 23 Dec 1998

• Vitalcare Powder Free Synthetic Vinyl Examination Glove

  Class I

  FDA 510(k) K040916 Active Cleared 4 May 2005

• Vitalcare Sterilewater and 0.9% Sodium Chloride Pre-Filled 10cc/30cc Syringes

  Class II

  FDA 510(k) K031748 Active Cleared 27 Aug 2003

• Vinyl Powdered Exam Glove / Cat.# 15-020

  Class I

  FDA 510(k) K992289 Active Cleared 4 Aug 1999

• Latex Patient Examination Glove, Cat. No. 1000M Powdered

  Class I

  FDA 510(k) K982901 Active Cleared 21 Dec 1998

• Vitalcare I.V. Administration Set

  Class II

  FDA 510(k) K050906 Active Cleared 23 Aug 2005

See all devices from Vitalcare Group, Inc. →