Cleared Traditional

Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088) - FDA 510(k) Clearance

Class I General Hospital device.

K220088 · Professional Latex Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
443d
Days
Class 1
Risk

K220088 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with C.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Professional Latex Sdn Bhd (Kawasan Perusahaan Kamunting Raya, MY). The FDA issued a Cleared decision on March 30, 2023 after a review of 443 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Professional Latex Sdn Bhd devices

Submission Details

510(k) Number K220088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2022
Decision Date March 30, 2023
Days to Decision 443 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 129d · This submission: 443d
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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K220088.
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
K230121 · Careglove Global Sdn. Bhd. · May 2023
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
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
K220644 · Yty Industry (Manjung) 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