Cleared Traditional

K220644 - Non-sterile

K220644 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 386-day FDA review.

K220644 · Yty Industry (Manjung) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
257d slower than avg
Panel avg: 129d · 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.

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 K220644.
Disposible Nitrile Gloves
K223280 · Holik Asia Group Co.,Ltd · May 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
K221983 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Apr 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K220088 · Professional Latex Sdn Bhd · Mar 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
K230002 · Mah Sing Healthcare Sdn. Bhd. · Mar 2023
Disposable Medical Nitrile Examination Gloves
K223895 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Mar 2023
Nitrile Examination Gloves
K222813 · Ecoglove Medical Manufacturing Company Limited · Mar 2023