Cleared Traditional

K093193 - LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)

K093193 is an FDA 510(k) clearance for LA GLOVE BRAND COLORED LATEX EXAMINATIO..., manufactured by La Glove (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K093193 · La Glove (M) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
238d
Days
Class 1
Risk

K093193 is an FDA 510(k) clearance for the LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY). The FDA issued a Cleared decision on June 8, 2010 after a review of 238 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 La Glove (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K093193

510(k) Number K093193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2009
Decision Date June 08, 2010
Days to Decision 238 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
109d slower than avg
Panel avg: 129d · This submission: 238d
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 612
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K093193.
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LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)
K092499 · La Glove (M) Sdn. Bhd. · Nov 2009
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
K083337 · Terang Nusa Sdn Bhd · Jan 2009