Ergo II, Surgical Latex Gloves

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884030 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Patient Exam Gloves (Mfg. Shun Tahi Rubber Gloves)

  Class I

  FDA 510(k) K892101 Active Cleared 8 May 1989

• Non-Sterile Patient Exam Gloves (Latex)

  Class I

  FDA 510(k) K892166 Active Cleared 14 Jul 1989

• Prolax Patient Examination Gloves (Latex)

  Class I

  FDA 510(k) K892026 Active Cleared 25 May 1989

• Patient Exam Gloves (Mfg. Shun Jun Trading Co.)

  Class I

  FDA 510(k) K892100 Active Cleared 8 May 1989