Cleared Traditional

K063627 - POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

K063627 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES ..., manufactured by Smart Glove Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K063627 · Smart Glove Corp. Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
104d
Days
Class 1
Risk

K063627 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Smart Glove Corp. Sdn Bhd (Klang Selangor, MY). The FDA issued a Cleared decision on March 20, 2007 after a review of 104 days - within the typical 510(k) review window.

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 Smart Glove Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K063627

510(k) Number K063627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2006
Decision Date March 20, 2007
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 1078
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K063627.
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
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K070097 · Gx Corporation Sdn Bhd · Mar 2007
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K062919 · Shen Wei (Usa), Inc. · Mar 2007
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POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
K070096 · Gx Corporation Sdn Bhd · Mar 2007
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K063777 · Bright Element Sdn Bhd · Feb 2007