Cleared Traditional

K170290 - Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

K170290 is an FDA 510(k) clearance for Powder Free Nitrile Exam Glove w/pH coating, manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K170290 · Shen Wei (Usa), Inc. · General Hospital
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May 2017
Decision
114d
Days
Class 1
Risk

K170290 is an FDA 510(k) clearance for the Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Us.... 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 May 24, 2017 after a review of 114 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K170290

510(k) Number K170290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date May 24, 2017
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K170290.
DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
K163035 · Elm Tree Medical, Inc. · Jul 2017
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K171339 · Eco Medi Glove Sdn. Bhd. · Jul 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
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Powder Free Nitrile Patient Examination Gloves, Blue
K163553 · Hebei Titans Medical Supply Technology Group., Ltd. · May 2017
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
K170393 · Zibo Chengxun Automatic Device Co., Ltd. · May 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K162294 · Brightway Holdings Sdn. Bhd. · Apr 2017