PATIENT EXAMINATION GLOVES— 510(k) K892505

Substantially Equivalent

Wango Intl., Inc.

FDA 510(k) clearance K892505 for PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1989-09-26. Applicant: Wango Intl., Inc.. Device class: 1.

Clearance details

Applicant: Wango Intl., Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-04-12
Decision date: 1989-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYZ

K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)2026-04-07
K252467 — Disposable Vinyl Examination Gloves2025-10-27
K252505 — Powder-Free Vinyl Exam Gloves, clear2025-08-28
K241252 — Disposable Vinyl Examination Gloves2024-05-20
K230046 — Vinyl examination gloves2023-03-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.