Cleared Traditional

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210774) - FDA 510(k) Clearance

Class I General Hospital device.

K210774 · Shandong Jieshi Medical Products Co., Ltd. · General Hospital
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May 2021
Decision
60d
Days
Class 1
Risk

K210774 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Jieshi Medical Products Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on May 14, 2021 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shandong Jieshi Medical Products Co., Ltd. devices

Submission Details

510(k) Number K210774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2021
Decision Date May 14, 2021
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 Easy-Link Company
Chu Xiaoan

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 K210774.
Disposable Vinyl Examination Gloves
K210522 · Shandong Shengshixincheng Medical Science & Technology Co., · 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)
K210780 · Shandong Shangwei Medical Products Co., Ltd. · May 2021
Powder Free Vinyl Patient Examination Gloves
K210799 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · May 2021
Single-use medical poly (vinyl chloride) examination glove
K201504 · Anhui Bytech Medical Supplies Co., Ltd. · May 2021