Cleared Traditional

K171743 - Powder Free Pink Polychloroprene Copoly...

K171743 is an FDA 510(k) clearance for Powder Free Pink Polychloroprene Copoly..., manufactured by Smart Glove Corporation Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K171743 · Smart Glove Corporation Sdn. Bhd. · General Hospital
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Nov 2017
Decision
158d
Days
Class 1
Risk

K171743 is an FDA 510(k) clearance for the Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Bl.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Smart Glove Corporation Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on November 17, 2017 after a review of 158 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 Smart Glove Corporation Sdn. Bhd. devices

FDA 510(k) Submission Details - K171743

510(k) Number K171743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2017
Decision Date November 17, 2017
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 685
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K171743.
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · Ansell Healthcare Products, LLC · Dec 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
K173137 · Hartalega Sdn Bhd · Dec 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678 · Shen Wei (Usa), Inc. · Nov 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442 · Hartalega NGC Sdn. Bhd. · Nov 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
K171874 · Hartalega Sdn Bhd · Oct 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104 · Yty Industry (Manjung) Sdn Bhd · Aug 2017