Cleared Traditional

Vinyl compound examination gloves (K211229) - FDA 510(k) Clearance

Class I General Hospital device.

K211229 · Hebei Titans Hongsen Medical Technology Co., Ltd. · General Hospital
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Jul 2021
Decision
97d
Days
Class 1
Risk

K211229 is an FDA 510(k) clearance for the Vinyl compound examination gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hebei Titans Hongsen Medical Technology Co., Ltd. (Nangong, CN). The FDA issued a Cleared decision on July 29, 2021 after a review of 97 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 Hebei Titans Hongsen Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K211229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date July 29, 2021
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray 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 K211229.
Vinyl Glove
K211904 · Jiangsu Dihong Industry and Trade Co., Ltd. · Sep 2021
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
K211516 · Tangshan Hongyun Plastic Products Co., Ltd. · Aug 2021
Disposable Synthetic Vinyl Nitrile Examination Glove
K211354 · Jiangsu Cureguard Glove Co., Ltd. · Aug 2021
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
K211262 · Tangshan Hongyun Healthcare Products Co., Ltd. · Jul 2021
Powder Free Vinyl Patient Examination Gloves
K211177 · Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. · Jul 2021
Vinyl Patient Examination Gloves
K211239 · Jiangxi Shengda Medical Technology Co., Ltd. · Jul 2021