Cleared Traditional

K171873 - Powder Free Nitrile Patient Examination...

K171873 is an FDA 510(k) clearance for Powder Free Nitrile Patient Examination..., manufactured by Zhonghong Pulin Medical Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K171873 · Zhonghong Pulin Medical Products Co., Ltd. · General Hospital
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Nov 2017
Decision
145d
Days
Class 1
Risk

K171873 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tes.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Zhonghong Pulin Medical Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on November 15, 2017 after a review of 145 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 Zhonghong Pulin Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K171873

510(k) Number K171873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2017
Decision Date November 15, 2017
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 683
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K171873.
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · Ansell Healthcare Products, LLC · Dec 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
K173137 · Hartalega Sdn Bhd · Dec 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678 · Shen Wei (Usa), Inc. · Nov 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442 · Hartalega NGC Sdn. Bhd. · Nov 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
K171874 · Hartalega Sdn Bhd · Oct 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104 · Yty Industry (Manjung) Sdn Bhd · Aug 2017