Cleared Traditional

K082302 - POWDER FREE NITRILE PATIENT EXAMINATION...

K082302 is the FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K082302 · Pt. Medisafe Technologies · General Hospital
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Dec 2008
Decision
119d
Days
Class 1
Risk

K082302 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM. 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 December 9, 2008 after a review of 119 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 Pt. Medisafe Technologies devices

Submission Details

510(k) Number K082302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2008
Decision Date December 09, 2008
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 K082302.
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568 · Medline Industries, Inc. · Oct 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652 · Hartalega Sdn Bhd · Sep 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
K090194 · Shen Wei (Usa), Inc. · Jul 2009
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594 · Medline Industries, Inc. · Oct 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260 · Kimberly-Clark Corp. · Jul 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
K081027 · Kimberly-Clark Corp. · Jun 2008