Cleared Traditional

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598) - FDA 510(k) Clearance

Class I General Hospital device.

K233598 · Anhui Intco Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
78d
Days
Class 1
Risk

K233598 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Anhui Intco Medical Products Co., Ltd. (Huaibei City, CN). The FDA issued a Cleared decision on January 26, 2024 after a review of 78 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 Anhui Intco Medical Products Co., Ltd. devices

Submission Details

510(k) Number K233598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2023
Decision Date January 26, 2024
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 K233598.
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · W.A. Rubbermate Co., Ltd. · Feb 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
K240072 · Luliang Hongruida Health Protection Technology Co., Ltd. · Feb 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232764 · Eco Medi Glove Sdn. Bhd. · Feb 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
K233970 · Nephron Nitrile, LLC · Jan 2024
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
K233520 · Anhui Powerguard Technology Co., Ltd. · Jan 2024
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
K233405 · Eco Medi Glove Sdn. Bhd. · Dec 2023