Cleared Traditional

K170393 - Powder Free Nitrile Examination Gloves ...

K170393 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ..., manufactured by Zibo Chengxun Automatic Device Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K170393 · Zibo Chengxun Automatic Device Co., Ltd. · General Hospital
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May 2017
Decision
90d
Days
Class 1
Risk

K170393 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and V.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Zibo Chengxun Automatic Device Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on May 9, 2017 after a review of 90 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 Zibo Chengxun Automatic Device Co., Ltd. devices

FDA 510(k) Submission Details - K170393

510(k) Number K170393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2017
Decision Date May 09, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 730
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K170393.
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
K170686 · Brightway Holdings Sdn. Bhd. · Jul 2017
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K170794 · Hartalega NGC Sdn. Bhd. · Jun 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
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K162294 · Brightway Holdings Sdn. Bhd. · Apr 2017
NITRILE EXAMINATION GLOVE
K163267 · Brightway Holdings Sdn. Bhd. · Mar 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646 · Hartalega NGC Sdn. Bhd. · Mar 2017