Cleared Traditional

Vinyl Examination Gloves (Yellow) (K203702) - FDA 510(k) Clearance

Class I General Hospital device.

K203702 · Xinying Trading Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
56d
Days
Class 1
Risk

K203702 is an FDA 510(k) clearance for the Vinyl Examination Gloves (Yellow). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Xinying Trading Co., Ltd. (Dezhou, CN). The FDA issued a Cleared decision on February 12, 2021 after a review of 56 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 Xinying Trading Co., Ltd. devices

Submission Details

510(k) Number K203702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date February 12, 2021
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 84
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K203702.
Single-use medical poly (vinyl chloride) examination glove
K201504 · Anhui Bytech Medical Supplies Co., Ltd. · May 2021
Vinyl Examination Gloves(Yellow)
K203666 · Lutai Medical Technology Co., Ltd. · Mar 2021
Disposable Vinyl Examination Gloves
K203439 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Feb 2021
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
K202179 · Medline Industries, Inc. · Oct 2020
Disposable Vinyl Glove
K202010 · Better Health Medical Products Co., Ltd. · Oct 2020
Disposable Vinyl Glove
K202008 · Best Care Trading Co., Ltd. · Sep 2020