Cleared Traditional

K062965 - CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM

K062965 is an FDA 510(k) clearance for CHLORINATED, manufactured by Kossan Latex Industries(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 84-day FDA review.

K062965 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
84d
Days
Class 1
Risk

K062965 is an FDA 510(k) clearance for the CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Annapolis, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062965

510(k) Number K062965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date December 22, 2006
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K062965.
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
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K062527 · Multisafe Sdn. Bhd. · Feb 2007
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
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688 · Ug Healthcare (Usa), Inc. · Nov 2006
K062965 · CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
Download PDF FDA Summary Kossan Latex Industri…