BYTECH— 510(k) K130101

Substantially Equivalent

Bytech Dongtai Co., Ltd.

FDA 510(k) clearance K130101 for BYTECH, Substantially Equivalent on 2013-11-08. Applicant: Bytech Dongtai Co., Ltd.. Device class: 1.

Clearance details

Applicant: Bytech Dongtai Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2013-01-15
Decision date: 2013-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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

More clearances from Bytech Dongtai Co., Ltd.

K212899 — Disposable Vinyl/Nitrile Blend Medical Examination Gloves2021-12-11

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