Cleared Traditional

K162095 - Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

K162095 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 97-day FDA review.

K162095 · Yty Industry (Manjung) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
97d
Days
Class 1
Risk

K162095 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 November 2, 2016 after a review of 97 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 - K162095

510(k) Number K162095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2016
Decision Date November 02, 2016
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162095.
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
K161944 · Shandong Baisheng Medical Products Co., Ltd. · Nov 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074 · Shen Wei (Usa), Inc. · Nov 2016
Powder Free Nitrile Examination Gloves (Blue)
K162113 · Nam Viet Glove Joint Stock Company · Nov 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K161422 · Wrp Asia Pacific Sdn. Bhd. · Oct 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473 · Medline Industries, Inc. · Oct 2016
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
K160562 · Hartalega Snd. Bhd. · Oct 2016