Cleared Traditional

K202536 - Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate

K202536 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 344-day FDA review.

K202536 · Yty Industry (Manjung) Sdn Bhd · General Hospital
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K202536

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.

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 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