Cleared Traditional

K171104 - Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)

K171104 is an FDA 510(k) clearance for Non-Sterile, manufactured by Yty Industry (Manjung) Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K171104 · Yty Industry (Manjung) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
134d
Days
Class 1
Risk

K171104 is an FDA 510(k) clearance for the Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chem.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Sitiawan, MY). The FDA issued a Cleared decision on August 25, 2017 after a review of 134 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 Yty Industry (Manjung) Sdn Bhd devices

FDA 510(k) Submission Details - K171104

510(k) Number K171104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2017
Decision Date August 25, 2017
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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 1020
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K171104.
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
K171378 · Semperit Investments Asia Pte , Ltd. · Sep 2017
Powder Free Nitrile Examination Glove
K171667 · Professional Latex Sdn Bhd · Sep 2017
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
K170136 · Shandong Feiyang Professional Gloves Co., Ltd. · Aug 2017
Xingyu Nitrile Powder Free Patient Examination Gloves, White color
K171615 · Shandong Xingyu Gloves Co., Ltd. · Jul 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · Shen Wei (Usa), Inc. · Jul 2017
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
K171616 · Shandong Xingyu Gloves Co., Ltd. · Jul 2017