Cleared Traditional

K152715 - HAINING NITRILE POWDER FREE PATIENT EXA...

K152715 is the FDA 510(k) clearance for HAINING NITRILE POWDER FREE PATIENT EXA... by Haining Medical Products Co., Ltd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K152715 · Haining Medical Products Co., Ltd. · General Hospital
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Feb 2016
Decision
157d
Days
Class 1
Risk

K152715 is an FDA 510(k) clearance for the HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Haining Medical Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on February 25, 2016 after a review of 157 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 Haining Medical Products Co., Ltd. devices

Submission Details

510(k) Number K152715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date February 25, 2016
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
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 613
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K152715.
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473 · Medline Industries, Inc. · Oct 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K160560 · Hartalega Sdn Bhd · Aug 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997 · Hartalega NGC Sdn. Bhd. · Mar 2016
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
K151836 · Hartalega NGC Sdn. Bhd. · Oct 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684 · Hartalega NGC Sdn. Bhd. · Sep 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
K151343 · Hartalega NGC Sdn. Bhd. · Aug 2015