Cleared Traditional

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K233042) - FDA 510(k) Clearance

Class I General Hospital device.

K233042 · Shandong Intco Medical Products Co, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
72d
Days
Class 1
Risk

K233042 is an FDA 510(k) clearance for the Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemothera.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shandong Intco Medical Products Co, Ltd. (Qingzhou, CN). The FDA issued a Cleared decision on December 6, 2023 after a review of 72 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 Shandong Intco Medical Products Co, Ltd. devices

Submission Details

510(k) Number K233042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date December 06, 2023
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K233042.
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
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
K233182 · Zibo Kaiyue Mould Technology Co., Ltd. · Dec 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
K232252 · Dehai (Shandong) Medical Gloves, Co., Ltd. · Nov 2023
Medical Nitrile Examination Gloves
K232576 · Jiangsu Complete Sincerity Medical New Materials Co., Ltd. · Nov 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
K232538 · Wrp Asia Pacific Sdn. Bhd. · Nov 2023