Cleared Traditional

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim (K220672) - FDA 510(k) Clearance

Class I General Hospital device.

K220672 · Riverstone Resources Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
88d
Days
Class 1
Risk

K220672 is an FDA 510(k) clearance for the Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy D.... 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 June 3, 2022 after a review of 88 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

Submission Details

510(k) Number K220672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date June 03, 2022
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K220672.
1st Glove Blue Nitrile Examination Gloves Powder Free
K221226 · Koove Iot Pvt. , Ltd. · Jun 2022
Zoupure Nitrile Powder Free Examination glove
K220693 · Thai Rayong Product Glove Zoupure Co., Ltd. · Jun 2022
Powder Free Nitrile Gloves
K213448 · St Future International Limited · Jun 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
K220541 · O&M Halyard, Inc. · Jun 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
K220547 · O&M Halyard, Inc. · Jun 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K220488 · Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · Jun 2022