Cleared Traditional

K233598 - 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 is an FDA 510(k) clearance for Powder Free Nitrile Examination Glove 2..., manufactured by Anhui Intco Medical Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

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

FDA 510(k) Submission Details - K233598

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.

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 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