Cleared Traditional

K252505 - Powder-Free Vinyl Exam Gloves, clear (FDA 510(k) Clearance)

Class I General Hospital device.

K252505 · Basic Medical Technology, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
20d
Days
Class 1
Risk

K252505 is an FDA 510(k) clearance for the Powder-Free Vinyl Exam Gloves, clear. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Basic Medical Technology, Inc. (Ontario, US). The FDA issued a Cleared decision on August 28, 2025 after a review of 20 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 Basic Medical Technology, Inc. devices

Submission Details

510(k) Number K252505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2025
Decision Date August 28, 2025
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K252505.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · Basic Medical Technology, Inc. · Apr 2026
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K252467 · Viet Phu Trade and Import Export Co., Ltd. · Oct 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