Cleared Traditional

K904526 - HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE

K904526 is an FDA 510(k) clearance for HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX..., manufactured by Malaytex USA, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K904526 · Malaytex USA, Inc. · General Hospital
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Nov 1990
Decision
53d
Days
Class 1
Risk

K904526 is an FDA 510(k) clearance for the HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Malaytex USA, Inc. (El Cerrito, US). The FDA issued a Cleared decision on November 23, 1990 after a review of 53 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 Malaytex USA, Inc. devices

FDA 510(k) Submission Details - K904526

510(k) Number K904526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1990
Decision Date November 23, 1990
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 721
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K904526.
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
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
K903107 · Ansell, Inc. · Aug 1990
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)
K903108 · Ansell, Inc. · Aug 1990
ALADAN TRI-CLEAN 110 POWDERLESS LATEX GLOVE
K902565 · Aladan Corp. · Jul 1990