Cleared Traditional

K063777 - ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE

K063777 is an FDA 510(k) clearance for ABLE GLOVE NITRILE BLUE POWDER FREE EXA..., manufactured by Bright Element Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K063777 · Bright Element Sdn Bhd · General Hospital
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Feb 2007
Decision
63d
Days
Class 1
Risk

K063777 is an FDA 510(k) clearance for the ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Bright Element Sdn Bhd (Subang Jaya, Selangor, MY). The FDA issued a Cleared decision on February 23, 2007 after a review of 63 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.

View all Bright Element Sdn Bhd devices

FDA 510(k) Submission Details - K063777

510(k) Number K063777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date February 23, 2007
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 878
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K063777.
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919 · Shen Wei (Usa), Inc. · Mar 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K063627 · Smart Glove Corp. Sdn Bhd · Mar 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
K070096 · Gx Corporation Sdn Bhd · Mar 2007
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
K063046 · Hartalega Sdn Bhd · Nov 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067 · Shen Wei (Usa), Inc. · Sep 2006
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
K061724 · Smart Glove Corp. Sdn Bhd · Jul 2006