Cleared Traditional

Disposable Vinyl Examination Gloves (K210522) - FDA 510(k) Clearance

Class I General Hospital device.

K210522 · Shandong Shengshixincheng Medical Science & Technology Co., · General Hospital
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Jun 2021
Decision
107d
Days
Class 1
Risk

K210522 is an FDA 510(k) clearance for the Disposable Vinyl Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Shengshixincheng Medical Science & Technology Co., (Binzhou, CN). The FDA issued a Cleared decision on June 10, 2021 after a review of 107 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 Shandong Shengshixincheng Medical Science & Technology Co., devices

Submission Details

510(k) Number K210522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2021
Decision Date June 10, 2021
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 K210522.
Medical PVC Examination Gloves
K210821 · Jiangxi Hongda Medical Equipment Group , Ltd. · Jul 2021
Synthetic Vinyl Examination Gloves
K211045 · Jiangsu Huayuan Medical Technology Co., Ltd. · Jun 2021
Disposable Vinyl Examination Glove
K211336 · Inner Mongolia Cureguard Medical Materials Co., Ltd. · Jun 2021
Disposable Synthetic Examination Gloves
K210520 · Shandong Shengshixincheng Medical Science & Technology Co., · May 2021
NitriTec Vinyl Glove Powder Free Blue
K210460 · Zhonghong Pulin Medical Products Co., Ltd. · May 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210774 · Shandong Jieshi Medical Products Co., Ltd. · May 2021