Cleared Special

K061551 - POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)

K061551 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Medipure Corporation (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Special 510(k) pathway after a 80-day FDA review.

K061551 · Medipure Corporation (M) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
80d
Days
Class 1
Risk

K061551 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medipure Corporation (M) Sdn. Bhd. (Ipoh, Perak, MY). The FDA issued a Cleared decision on August 24, 2006 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061551

510(k) Number K061551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date August 24, 2006
Days to Decision 80 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K061551.
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K062955 · Pt. Haloni Jane · Nov 2006
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
K061233 · Pt Mahakarya Inti Buana · Nov 2006
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
K062917 · Wear Safe Malaysia Sdn. Bhd. · Nov 2006
LATEX POWDERED EXAMINATION GLOVE
K060858 · High Momentum Sdn Bhd · Jun 2006
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
K053305 · Pt Mahakarya Inti Buana · Jun 2006
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
K061078 · Bright Element Sdn Bhd · May 2006
K061551 · POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
Download PDF FDA Summary Medipure Corporation …