Cleared Traditional

mCare Powder-free Blue Nitrile Examination Gloves (K172930) - FDA 510(k) Clearance

Class I General Hospital device.

K172930 · Mercator Medical (Thailand), Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
200d
Days
Class 1
Risk

K172930 is an FDA 510(k) clearance for the mCare Powder-free Blue Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mercator Medical (Thailand), Ltd. (Amphur Rattaphum, TH). The FDA issued a Cleared decision on April 13, 2018 after a review of 200 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 Mercator Medical (Thailand), Ltd. devices

Submission Details

510(k) Number K172930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2017
Decision Date April 13, 2018
Days to Decision 200 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 129d · This submission: 200d
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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K172930.
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
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
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
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982 · Medline Industries, Inc. · Feb 2017