Cleared Traditional

K220088 - Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K220088 is an FDA 510(k) clearance for Powder Free Nitrile Examination Glove, manufactured by Professional Latex Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 443-day FDA review.

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

FDA 510(k) Submission Details - K220088

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.

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 1157
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