Cleared Traditional

K102623 - BLUE POWDERFREE NITRILE EXAMINATION GLOVE

K102623 is the FDA 510(k) clearance for BLUE POWDERFREE NITRILE EXAMINATION GLOVE by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K102623 · Pt. Medisafe Technologies · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2011
Decision
266d
Days
Class 1
Risk

K102623 is an FDA 510(k) clearance for the BLUE POWDERFREE NITRILE EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, North Sumatra, ID). The FDA issued a Cleared decision on June 6, 2011 after a review of 266 days - an extended review 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: 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 Pt. Medisafe Technologies devices

Submission Details

510(k) Number K102623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2010
Decision Date June 06, 2011
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 555
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K102623.
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
K120890 · Shen Wei (Usa), Inc. · Aug 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
K113423 · Kimberly-Clark Corp. · Mar 2012
NITRILE POWDER FREE EXAMINATION GLOVES
K110758 · Hartalega Sdn Bhd · Aug 2011
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K092411 · Shen Wei (Usa), Inc. · Oct 2009