Cleared Traditional

K171615 - Xingyu Nitrile Powder Free Patient Exam...

K171615 is an FDA 510(k) clearance for Xingyu Nitrile Powder Free Patient Exam..., manufactured by Shandong Xingyu Gloves Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K171615 · Shandong Xingyu Gloves Co., Ltd. · General Hospital
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Jul 2017
Decision
60d
Days
Class 1
Risk

K171615 is an FDA 510(k) clearance for the Xingyu Nitrile Powder Free Patient Examination Gloves, White color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shandong Xingyu Gloves Co., Ltd. (Gaomi, CN). The FDA issued a Cleared decision on July 31, 2017 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shandong Xingyu Gloves Co., Ltd. devices

FDA 510(k) Submission Details - K171615

510(k) Number K171615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date July 31, 2017
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K171615.
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Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
K170794 · Hartalega NGC Sdn. Bhd. · Jun 2017