Cleared Traditional

K954967 - GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES

K954967 is an FDA 510(k) clearance for GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES, manufactured by Guthrie Medicare Products (Melaka) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K954967 · Guthrie Medicare Products (Melaka) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
168d
Days
Class 1
Risk

K954967 is an FDA 510(k) clearance for the GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Guthrie Medicare Products (Melaka) Sdn Bhd (Tucson, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 168 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 Guthrie Medicare Products (Melaka) Sdn Bhd devices

FDA 510(k) Submission Details - K954967

510(k) Number K954967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date April 15, 1996
Days to Decision 168 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 129d · This submission: 168d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K954967.
NIL LATEX POWDERFREE EXAMINATION GLOVES
K955341 · Shangrila Latex Industries Pvt. , Ltd. · Apr 1996
PREPOWDERED LATEX EXAMINATION GLOVES
K955888 · Pantai Utama Sdn. Bhd. · Apr 1996
POWDERFREE LATEX EXAMINATION GLOVES
K955889 · Pantai Utama Sdn. Bhd. · Apr 1996
PRE POWDERED LATEX EXAMINATION GLOVES
K954487 · Ganz Industries Sdn. Bhd. · Mar 1996
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415 · Hartalega Sdn Bhd · Mar 1996
DERMATOUCH LATEX GLOVES
K955670 · Concordia Research Lab · Mar 1996