Cleared Traditional

DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED (K082448) - FDA 510(k) Clearance

Class I General Hospital device.

K082448 · Rich Mountain Medical Products, Inc. · General Hospital
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Dec 2008
Decision
107d
Days
Class 1
Risk

K082448 is an FDA 510(k) clearance for the DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Rich Mountain Medical Products, Inc. (Pizhou, Jiangsu, CN). The FDA issued a Cleared decision on December 10, 2008 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 Rich Mountain Medical Products, Inc. devices

Submission Details

510(k) Number K082448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2008
Decision Date December 10, 2008
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 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 K082448.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
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Powder-Free Vinyl Exam Gloves, clear
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K241252 · Anqing Pukang Medical Technology Co., Ltd. · May 2024
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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