Cleared Traditional

K091965 - POWDER FREE NITRILE EXAMINATION GLOVES ...

Also marketed or referenced as:
BLUE, GRAPE SCENTED

K091965 is the FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES ... 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 146-day FDA review.

K091965 · Platinum Glove Industries Sdn. Bhd. · General Hospital
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Nov 2009
Decision
146d
Days
Class 1
Risk

K091965 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES BLACK. 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 November 24, 2009 after a review of 146 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 K091965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date November 24, 2009
Days to Decision 146 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 slower than avg
Panel avg: 129d · This submission: 146d
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 K091965.
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