Cleared Traditional

K171378 - Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs

K171378 is an FDA 510(k) clearance for Non-Sterile, manufactured by Semperit Investments Asia Pte , Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K171378 · Semperit Investments Asia Pte , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
127d
Days
Class 1
Risk

K171378 is an FDA 510(k) clearance for the Non-Sterile, Single use, Powder-free examination glove tested for use with Ch.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Semperit Investments Asia Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on September 14, 2017 after a review of 127 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 Semperit Investments Asia Pte , Ltd. devices

FDA 510(k) Submission Details - K171378

510(k) Number K171378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2017
Decision Date September 14, 2017
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 Consultant

Mansour Consulting, LLC
Jay Mansour

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1169
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K171378.
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