Cleared Traditional

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223415) - FDA 510(k) Clearance

Class I General Hospital device.

K223415 · Mah Sing Healthcare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
77d
Days
Class 1
Risk

K223415 is an FDA 510(k) clearance for the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mah Sing Healthcare Sdn. Bhd. (Kuala Lumpur, MY). The FDA issued a Cleared decision on January 26, 2023 after a review of 77 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 Mah Sing Healthcare Sdn. Bhd. devices

Submission Details

510(k) Number K223415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2022
Decision Date January 26, 2023
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 K223415.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
K223559 · Nephron Pharmaceuticals Corporation · Feb 2023
Powder Free Blue Nitrile Examination Glove
K223444 · S&S Glove Corporation · Feb 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102)
K223903 · Semperit Investments Asia Pte , Ltd. · Jan 2023
Synthetic Polymer Glove - Polyethylene (Black)
K222531 · Ur Industry Sdn Bhd · Jan 2023
Disposable Nitrile Examination Glove
K223250 · Yangzhou Saraguard Medical Supplies Co., Ltd. · Jan 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · Dynacare Sdn Bhd · Jan 2023