Cleared Traditional

K080165 - SMART SAVERS POWDER FREE NITRILE EXAMIN...

K080165 is the FDA 510(k) clearance for SMART SAVERS POWDER FREE NITRILE EXAMIN... by Platinum Glove Industries Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K080165 · Platinum Glove Industries Sdn. Bhd. · General Hospital
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May 2008
Decision
112d
Days
Class 1
Risk

K080165 is an FDA 510(k) clearance for the SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Platinum Glove Industries Sdn. Bhd. (Shah Alam, Selangor, MY). The FDA issued a Cleared decision on May 14, 2008 after a review of 112 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 Platinum Glove Industries Sdn. Bhd. devices

Submission Details

510(k) Number K080165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2008
Decision Date May 14, 2008
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 584
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K080165.
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
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
K080520 · Siam Sempermed Corp., Ltd. · Apr 2008
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
K071910 · Hartalega Sdn Bhd · Sep 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639 · Siam Sempermed Corp., Ltd. · Jun 2007