Cleared Traditional

K062526 - BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

K062526 is an FDA 510(k) clearance for BLUE POWDERED LATEX EXAMINATION GLOVES, manufactured by Multisafe Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K062526 · Multisafe Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
228d
Days
Class 1
Risk

K062526 is an FDA 510(k) clearance for the BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Multisafe Sdn. Bhd. (35500 Bidor, Perak Darul Ridzu, MY). The FDA issued a Cleared decision on April 13, 2007 after a review of 228 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 Multisafe Sdn. Bhd. devices

FDA 510(k) Submission Details - K062526

510(k) Number K062526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date April 13, 2007
Days to Decision 228 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 129d · This submission: 228d
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 912
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K062526.
POWDERED LATEX EXAMINATION GLOVES
K071323 · Quality Gallant Sdn. Bhd. · Jun 2007
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
K070760 · Derma Care Plus Products, LLC · Jun 2007
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
K070821 · Medtexx Manufacturing Sdn. Bhd. · May 2007
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
K063581 · Pt Mahakarya Inti Buana · Mar 2007
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES
K070072 · Medtexx Manufacturing Sdn. Bhd. · Mar 2007
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
K063776 · Bright Element Sdn Bhd · Mar 2007