Cleared Traditional

K063627 - POWDER FREE NITRILE EXAMINATION GLOVES ...

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 641
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K063627.
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639 · Siam Sempermed Corp., Ltd. · Jun 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
K061756 · Shen Wei (Usa), Inc. · Apr 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919 · Shen Wei (Usa), Inc. · 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