Cleared Traditional

K063776 - ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES

K063776 is an FDA 510(k) clearance for ABLE GLOVE LATEX POWDERED EXAMINATION G..., manufactured by Bright Element Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K063776 · Bright Element Sdn Bhd · General Hospital
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Mar 2007
Decision
71d
Days
Class 1
Risk

K063776 is an FDA 510(k) clearance for the ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Bright Element Sdn Bhd (Subang Jaya, Selangor, MY). The FDA issued a Cleared decision on March 2, 2007 after a review of 71 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 - K063776

510(k) Number K063776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date March 02, 2007
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
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 1364
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K063776.
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K062526 · Multisafe Sdn. Bhd. · Apr 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
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K062527 · Multisafe Sdn. Bhd. · Feb 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
K063776 · ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
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