Cleared Traditional

K171378 - Non-Sterile

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
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 Peers - LZA Polymer Patient Examination Glove

All 702
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K171378.
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678 · Shen Wei (Usa), Inc. · Nov 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442 · Hartalega NGC Sdn. Bhd. · 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
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104 · Yty Industry (Manjung) Sdn Bhd · Aug 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · Shen Wei (Usa), Inc. · Jul 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
K170686 · Brightway Holdings Sdn. Bhd. · Jul 2017