Cleared Traditional

K172923 - Nitrile Examination Powder Free Glove

K172923 is the FDA 510(k) clearance for Nitrile Examination Powder Free Glove by Top Glove Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K172923 · Top Glove Sdn. Bhd. · General Hospital
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Apr 2018
Decision
213d
Days
Class 1
Risk

K172923 is an FDA 510(k) clearance for the Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examinat.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Top Glove Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on April 26, 2018 after a review of 213 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 Top Glove Sdn. Bhd. devices

Submission Details

510(k) Number K172923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2017
Decision Date April 26, 2018
Days to Decision 213 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
84d slower than avg
Panel avg: 129d · This submission: 213d
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 612
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K172923.
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422 · Ever Global (Vietnam) Enterprise Corp · Jun 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
K172867 · Gmp Medicare Sdn Bhd (F25) · May 2018
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
K180696 · Medline Industries, Inc. · Apr 2018
mCare Powder-free Blue Nitrile Examination Gloves
K172930 · Mercator Medical (Thailand), Ltd. · Apr 2018
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
K171171 · Koon Seng Sdn Bhd · Feb 2018
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
K173228 · Jiangsu U-Med Rubber & Plastic Products Co., Ltd. · Feb 2018