Cleared Traditional

K062527 - BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

K062527 is an FDA 510(k) clearance for BLUE POWDER FREE 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 176-day FDA review.

K062527 · Multisafe Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
176d
Days
Class 1
Risk

K062527 is an FDA 510(k) clearance for the BLUE POWDER FREE 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 February 20, 2007 after a review of 176 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 - K062527

510(k) Number K062527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date February 20, 2007
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 K062527.
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
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062965 · Kossan Latex Industries(M)Sdn Bhd · Dec 2006
POWDER FREE LATEX EXAMINATION GLOVES, BLACK
K062709 · Pt. Maja Agung Latexindo · Dec 2006
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
K062313 · Pt Mahakarya Inti Buana · Nov 2006