Cleared Traditional

K110250 - MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES

K110250 is an FDA 510(k) clearance for MPXX POWDER FREE NATURAL RUBBER EXAMINA..., manufactured by Total Gloves Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K110250 · Total Gloves Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
259d
Days
Class 1
Risk

K110250 is an FDA 510(k) clearance for the MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Total Gloves Sdn Bhd (Taiping, Perak, MY). The FDA issued a Cleared decision on October 14, 2011 after a review of 259 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.

FDA 510(k) Submission Details - K110250

510(k) Number K110250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date October 14, 2011
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 129d · This submission: 259d
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 1288
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K110250.
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
K112612 · Top Calibre Sdn Bhd · Jan 2012
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
K112988 · Northstar Healthcare Holdings Limited · Nov 2011
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K111923 · Pt. Intan Hevea Industry · Nov 2011
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K111158 · Innovative Gloves Co;, Ltd. · Aug 2011
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
K111133 · Ssc Surat Thani · Jun 2011
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
K100895 · Dipped Products Limited · May 2011
K110250 · MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
Download PDF FDA Summary Total Gloves Sdn Bhd