Cleared Traditional

Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K221350) - FDA 510(k) Clearance

Class I General Hospital device.

K221350 · Rubberex Alliance Products Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
87d
Days
Class 1
Risk

K221350 is an FDA 510(k) clearance for the Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemo.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Rubberex Alliance Products Sdn Bhd (Ipoh, MY). The FDA issued a Cleared decision on August 5, 2022 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rubberex Alliance Products Sdn Bhd devices

Submission Details

510(k) Number K221350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2022
Decision Date August 05, 2022
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 Consultant

Mdi Consultants, Inc.
Kewin Tham

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K221350.
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
K213937 · O&M Halyard, Inc. · Aug 2022
Pro Guard Nitrile Powder Free Examination Glove
K213934 · Medical Glove Co., Ltd. · Aug 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
K213993 · Careglove Global Sdn. Bhd. · Aug 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K213929 · O&M Halyard, Inc. · Aug 2022
Disposable Medical Nitrile Examination Gloves
K220237 · Fujian Jixiang Medical Technology Co.,Ltd · Aug 2022
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
K221773 · Onetexx Sdn Bhd · Jul 2022