Cleared Traditional

K153510 - Powder Free Polychloroprene Examination Glove Green

K153510 is an FDA 510(k) clearance for Powder Free Polychloroprene Examination..., manufactured by Terang Nusa Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K153510 · Terang Nusa Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
105d
Days
Class 1
Risk

K153510 is an FDA 510(k) clearance for the Powder Free Polychloroprene Examination Glove Green. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (Kota Bharu, MY). The FDA issued a Cleared decision on March 21, 2016 after a review of 105 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 Terang Nusa Sdn Bhd devices

FDA 510(k) Submission Details - K153510

510(k) Number K153510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date March 21, 2016
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K153510.
Powder Free Blue Nitrile Examination Glove
K153562 · Vietglove Corporation · Apr 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997 · Hartalega NGC Sdn. Bhd. · Mar 2016
Halyard Black-Orange Powder-Free Nitrile Exam Glove
K153708 · Halyard Health · Mar 2016
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
K152705 · Jiayuan Medical Products Co., Ltd. · Mar 2016
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
K152707 · Minghao Medical Products Co., Ltd. · Mar 2016
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
K152720 · Xingda Medical Products Co., Ltd. · Mar 2016