Cleared Traditional

K131440 - POWDER FREE NITRILE PATIENT EXAMINATION...

K131440 is an FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION..., manufactured by Hebei Hongsen Plastics Technology Co, Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K131440 · Hebei Hongsen Plastics Technology Co, Ltd. · General Hospital
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Sep 2013
Decision
128d
Days
Class 1
Risk

K131440 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hebei Hongsen Plastics Technology Co, Ltd. (Pennington, US). The FDA issued a Cleared decision on September 25, 2013 after a review of 128 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.

View all Hebei Hongsen Plastics Technology Co, Ltd. devices

FDA 510(k) Submission Details - K131440

510(k) Number K131440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date September 25, 2013
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
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 732
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K131440.
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K132484 · Wrp Asia Pacific Sdn. Bhd. · Dec 2013
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841 · Kimberly-Clark Corp. · Nov 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
K132006 · Hartalega Sdn Bhd · Nov 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
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POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749 · Kossan Latex Industries(M)Sdn Bhd · Mar 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · Cardinal Health, Inc. · Jan 2013