Cleared Traditional

K172867 - Nitrile Examination Powder Free Glove

K172867 is the FDA 510(k) clearance for Nitrile Examination Powder Free Glove by Gmp Medicare Sdn Bhd (F25). It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K172867 · Gmp Medicare Sdn Bhd (F25) · General Hospital
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May 2018
Decision
232d
Days
Class 1
Risk

K172867 is an FDA 510(k) clearance for the Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Gmp Medicare Sdn Bhd (F25) (Klang, MY). The FDA issued a Cleared decision on May 10, 2018 after a review of 232 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 Gmp Medicare Sdn Bhd (F25) devices

Submission Details

510(k) Number K172867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2017
Decision Date May 10, 2018
Days to Decision 232 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
103d slower than avg
Panel avg: 129d · This submission: 232d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K172867.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
K180505 · Hartalega Sdn Bhd · Jun 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452 · Riverstone Resources Sdn Bhd · Jun 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422 · Ever Global (Vietnam) Enterprise Corp · Jun 2018
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
K180696 · Medline Industries, Inc. · Apr 2018
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
K172923 · Top Glove Sdn. Bhd. · Apr 2018
mCare Powder-free Blue Nitrile Examination Gloves
K172930 · Mercator Medical (Thailand), Ltd. · Apr 2018