Cleared Traditional

K913531 - PATIENT EXAMINATION GLOVEWS

K913531 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVEWS, manufactured by Pt. Sarana Indoprotex. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K913531 · Pt. Sarana Indoprotex · General Hospital
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Jan 1992
Decision
152d
Days
Class 1
Risk

K913531 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVEWS. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Sarana Indoprotex (Lampung 35001-Iodonesia, IO). The FDA issued a Cleared decision on January 7, 1992 after a review of 152 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 Pt. Sarana Indoprotex devices

FDA 510(k) Submission Details - K913531

510(k) Number K913531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1991
Decision Date January 07, 1992
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
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 444
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K913531.
COMFIT STERILE LATEX EXAMINATION GLOVE
K922513 · Wembley Rubber Products (M) Sdn Bhd · Aug 1992
AUDIOTONE MODEL A97
K920092 · Miracle-Ear, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K913409 · Top Glove Sdn. Bhd. · Sep 1991
LATEX EXAMINATION GLOVES
K912988 · La Glove (M) Sdn. Bhd. · Aug 1991
ALADAN LATEX MEDICAL GLOVE
K911774 · Aladan Corp. · May 1991