Cleared Traditional

K162312 - Biodegradable Powder Free Nitrile Exam ...

K162312 is the FDA 510(k) clearance for Biodegradable Powder Free Nitrile Exam ... by Shen Wei (Usa), Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K162312 · Shen Wei (Usa), Inc. · General Hospital
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Jul 2017
Decision
341d
Days
Class 1
Risk

K162312 is an FDA 510(k) clearance for the Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on July 25, 2017 after a review of 341 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 Shen Wei (Usa), Inc. devices

Submission Details

510(k) Number K162312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2016
Decision Date July 25, 2017
Days to Decision 341 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 129d · This submission: 341d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162312.
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 Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
K171874 · Hartalega Sdn Bhd · Oct 2017
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
K170290 · Shen Wei (Usa), Inc. · May 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982 · Medline Industries, Inc. · Feb 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491 · Hartalega Sdn Bhd · Feb 2017