Cleared Traditional

K960315 - FLAVORED LATEX PATIENT EXAMINATION

K960315 is an FDA 510(k) clearance for FLAVORED LATEX PATIENT EXAMINATION, manufactured by P.T. Irama Dinamika Latex. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K960315 · P.T. Irama Dinamika Latex · General Hospital
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Nov 1996
Decision
302d
Days
Class 1
Risk

K960315 is an FDA 510(k) clearance for the FLAVORED LATEX PATIENT EXAMINATION. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by P.T. Irama Dinamika Latex (Indonesia, ID). The FDA issued a Cleared decision on November 20, 1996 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 P.T. Irama Dinamika Latex devices

FDA 510(k) Submission Details - K960315

510(k) Number K960315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1996
Decision Date November 20, 1996
Days to Decision 302 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
173d slower than avg
Panel avg: 129d · This submission: 302d
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 440
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K960315.
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K970297 · Omni Sales Corp. · Feb 1997
DERLIN
K964817 · Derlin Company , Ltd. · Jan 1997
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563 · Omni Sales Corp. · Dec 1996
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996
TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
K960590 · Aladan Corp. · Oct 1996
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
K953213 · Wembley Rubber Products (M) Sdn Bhd · Oct 1996