Cleared Traditional

K904839 - PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE)

K904839 is an FDA 510(k) clearance for PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENT..., manufactured by Up TO Date, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K904839 · Up TO Date, Inc. · General Hospital
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Feb 1991
Decision
117d
Days
Class 1
Risk

K904839 is an FDA 510(k) clearance for the PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Up TO Date, Inc. (Miami, US). The FDA issued a Cleared decision on February 12, 1991 after a review of 117 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 Up TO Date, Inc. devices

FDA 510(k) Submission Details - K904839

510(k) Number K904839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1990
Decision Date February 12, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 720
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K904839.
ALADAN LATEX MEDICAL GLOVE
K911774 · Aladan Corp. · May 1991
LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
K911447 · Aladan Corp. · Apr 1991
LATEX PATIENT EXAMINATION GLOVES
K911081 · Medical Device Inspection Co., Inc. · Mar 1991
ALADERM
K905678 · Aladan Corp. · Jan 1991
PATIENT EXAMINATION GLOVES
K905551 · Johnson & Johnson Medical, Inc. · Jan 1991
PATIENT EXAMINATION GLOVES
K905550 · Medical Device Inspection Co., Inc. · Dec 1990