Cleared Traditional

K202536 - Non-sterile

K202536 is the FDA 510(k) clearance for Non-sterile by Yty Industry (Manjung) Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K202536 · Yty Industry (Manjung) Sdn Bhd · General Hospital
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Aug 2021
Decision
344d
Days
Class 1
Risk

K202536 is an FDA 510(k) clearance for the Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis.... 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 11, 2021 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K202536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date August 11, 2021
Days to Decision 344 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
215d slower than avg
Panel avg: 129d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K202536.
Disposable Medical Nitrile Gloves
K211708 · Jiangsu Health-Peace Medical Technology Co., Ltd. · Aug 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · Rhino Health, Inc. · Aug 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211860 · Anhui Powerguard Technology Co., Ltd. · Aug 2021
Nitrile Patient Examination Glove
K210730 · American Performance Polymers, LLC · Aug 2021
Edma Synthetic Nitrile Examination Gloves
K211540 · Edma Group, LLC · Aug 2021
Nitrile Patient Examination Glove
K210725 · Pingan Medical Products Co., Ltd. · Aug 2021