Cleared Traditional

K925363 - HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES

K925363 is an FDA 510(k) clearance for HYPOALLERGENIC MULTI-COMFORT EXAMINATIO..., manufactured by Perusahaan Intan Emas Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K925363 · Perusahaan Intan Emas Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
257d
Days
Class 1
Risk

K925363 is an FDA 510(k) clearance for the HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Perusahaan Intan Emas Sdn. Bhd. (56100 Kuala Lumpur, Malaysia, MY). The FDA issued a Cleared decision on July 6, 1993 after a review of 257 days - an extended review 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: 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 Perusahaan Intan Emas Sdn. Bhd. devices

FDA 510(k) Submission Details - K925363

510(k) Number K925363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date July 06, 1993
Days to Decision 257 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 129d · This submission: 257d
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 479
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K925363.
COMFIT BLUE POWDER FREE EXAMINATION GLOVE
K934813 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
DIGITEX, DIGITEX HYPOALLERGENIC
K926049 · Mayer Laboratories · Jul 1993
NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
K925683 · Arista Latindo Industrial Ltd. P.T · Jun 1993
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993