Cleared Traditional

K220401 - Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim

K220401 is an FDA 510(k) clearance for Pink Powder Free Nitrile Examination Gl..., manufactured by Riverstone Resources Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K220401 · Riverstone Resources Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
57d
Days
Class 1
Risk

K220401 is an FDA 510(k) clearance for the Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemothera.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Riverstone Resources Sdn Bhd (Taiping, MY). The FDA issued a Cleared decision on April 9, 2022 after a review of 57 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 Riverstone Resources Sdn Bhd devices

FDA 510(k) Submission Details - K220401

510(k) Number K220401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2022
Decision Date April 09, 2022
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 K220401.
Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
K220121 · Aamedix Glove Sdn Bhd · Apr 2022
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
K220209 · Ksg Medicare Sdn. Bhd. · Apr 2022
Nitrile Examination Gloves
K212929 · Watchtower Ppe Supplies, Inc. · Apr 2022
ELAZ Nitrile Powder Free Examination Glove
K213604 · Protect Gloves Co., Ltd. · Apr 2022
Medical Nitrile Examination Gloves
K220066 · Hunan Zhenheyikang Medical Instrument Co., Ltd. · Apr 2022
Nitrile Examination Gloves
K220343 · Nb Medical Co., Ltd. · Apr 2022