Cleared Traditional

K142270 - LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE

K142270 is an FDA 510(k) clearance for LATEX POWDERED EXAMINATION GLOVES WITH ..., manufactured by Hartalega Sdb. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K142270 · Hartalega Sdb. Bhd. · General Hospital
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Nov 2014
Decision
102d
Days
Class 1
Risk

K142270 is an FDA 510(k) clearance for the LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hartalega Sdb. Bhd. (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on November 25, 2014 after a review of 102 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K142270

510(k) Number K142270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date November 25, 2014
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 939
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K142270.
Annuy Latex Patient Examination Glove (powdered and powder-free)
K150612 · Anhui Anyu Latex Products Co., Ltd. · Nov 2015
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
K141042 · Mercator Medical (Thailand), Ltd. · Mar 2015
Patient Examination Gloves
K143419 · Hartalega NGC Sdn. Bhd. · Mar 2015
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
POWDER FREE LATEX EXAMINATION GLOVES
K123537 · Qube Medical Product Sdn Bhd · Feb 2014
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K121844 · Worldmed Manufacturing Sdn. Bhd. · Sep 2013