Cleared Traditional

Vinyl Examination Gloves (K213006) - FDA 510(k) Clearance

Class I General Hospital device.

K213006 · Taian Hengchang Medical Technology Co., Ltd. · General Hospital
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Dec 2021
Decision
92d
Days
Class 1
Risk

K213006 is an FDA 510(k) clearance for the Vinyl Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Taian Hengchang Medical Technology Co., Ltd. (Taian City, CN). The FDA issued a Cleared decision on December 21, 2021 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Taian Hengchang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K213006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date December 21, 2021
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K213006.
Vinyl Exam Gloves
K213019 · Hebei Astro Medical Supply Co., Ltd. · Jan 2022
NBR Synthetic Nitrile Examination Gloves
K212436 · Shandong Langtai International Trade Co., Ltd. · Dec 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
K213144 · Shen Wei (Usa), Inc. · Dec 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K211865 · Liao Ning Shangwei Medical Products Co., Ltd. · Dec 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
K212899 · Bytech Dongtai Co., Ltd. · Dec 2021
Synthetic Nitrile Examination Gloves
K212488 · Shandong Hongxin Chemicals Co., Ltd. · Nov 2021