Cleared Traditional

K141042 - MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES

K141042 is an FDA 510(k) clearance for MCARE PF POWDER FREE LATEX EXAMINATION ..., manufactured by Mercator Medical (Thailand), Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K141042 · Mercator Medical (Thailand), Ltd. · General Hospital
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Mar 2015
Decision
330d
Days
Class 1
Risk

K141042 is an FDA 510(k) clearance for the MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Mercator Medical (Thailand), Ltd. (Littleton, US). The FDA issued a Cleared decision on March 19, 2015 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K141042

510(k) Number K141042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2014
Decision Date March 19, 2015
Days to Decision 330 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
201d slower than avg
Panel avg: 129d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 784
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K141042.
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006 · Hartalega Sdn Bhd · Aug 2016
LATEX EXAMINATION GLOVE POWDER FREE
K152593 · Careplus (M) Sdn Bhd · Feb 2016
Annuy Latex Patient Examination Glove (powdered and powder-free)
K150612 · Anhui Anyu Latex Products Co., Ltd. · Nov 2015
Patient Examination Gloves
K143419 · Hartalega NGC Sdn. Bhd. · Mar 2015
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
K142270 · Hartalega Sdb. Bhd. · Nov 2014
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953 · Hartalega Sdn Bhd · May 2014