Cleared Traditional

K220644 - Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K220644 · Yty Industry (Manjung) Sdn Bhd · General Hospital

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Mar 2023

Decision

386d

Days

Class 1

Risk

K220644 is an FDA 510(k) clearance for the Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Do.... 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 March 25, 2023 after a review of 386 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	K220644 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 04, 2022
Decision Date	March 25, 2023
Days to Decision	386 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

258d slower than avg

Panel avg: 128d · This submission: 386d

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.