Cleared Traditional

K172930 - mCare Powder-free Blue Nitrile Examinat...

K172930 is an FDA 510(k) clearance for mCare Powder-free Blue Nitrile Examinat..., manufactured by Mercator Medical (Thailand), Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 200-day FDA review.

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

FDA 510(k) Submission Details - K172930

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.

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 682
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
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · Ansell Healthcare Products, LLC · Dec 2017