Cleared Traditional

K252467 - Disposable Vinyl Examination Gloves (FDA 510(k) Clearance)

Class I General Hospital device.

K252467 · Viet Phu Trade and Import Export Co., Ltd. · General Hospital
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Oct 2025
Decision
82d
Days
Class 1
Risk

K252467 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 Viet Phu Trade and Import Export Co., Ltd. (Dong Trieu, VN). The FDA issued a Cleared decision on October 27, 2025 after a review of 82 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 Viet Phu Trade and Import Export Co., Ltd. devices

Submission Details

510(k) Number K252467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2025
Decision Date October 27, 2025
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 128d · This submission: 82d
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 Peers - LYZ Vinyl Patient Examination Glove

All 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K252467.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · Basic Medical Technology, Inc. · Apr 2026
Powder-Free Vinyl Exam Gloves, clear
K252505 · Basic Medical Technology, Inc. · Aug 2025
Disposable Vinyl Examination Gloves
K241252 · Anqing Pukang Medical Technology Co., Ltd. · May 2024
Vinyl examination gloves
K230046 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Mar 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980 · Ever Global (Vietnam) Enterprise Corporation · Feb 2023
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
K220992 · Ever Global (Vietnam) Enterprise Corporation · Oct 2022