Cleared Traditional

K153732 - Powder Free Blue Nitrile Examination Glove

K153732 is an FDA 510(k) clearance for Powder Free Blue Nitrile Examination Glove, manufactured by Qube Medical Product Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K153732 · Qube Medical Product Sdn Bhd · General Hospital
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Jul 2016
Decision
214d
Days
Class 1
Risk

K153732 is an FDA 510(k) clearance for the Powder Free Blue Nitrile Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Qube Medical Product Sdn Bhd (Rawang, MY). The FDA issued a Cleared decision on July 29, 2016 after a review of 214 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.

FDA 510(k) Submission Details - K153732

510(k) Number K153732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date July 29, 2016
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
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 1172
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K153732.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
K151750 · Kossan International Sdn Bhd · Aug 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
K151824 · Kossan International Sdn Bhd · Aug 2016
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
K160467 · Kossan International Sdn Bhd · Aug 2016
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
K152937 · Eco Medi Glove Sdn. Bhd. · Jun 2016
Nitrile Patient Examination gloves, Powderfree, Blue color
K143477 · Primus Gloves Pvt Limited · Apr 2016
HG Pro Nitrile Powder Free Examination Gloves
K152479 · Healthy Glove Co., Ltd. · Apr 2016