Cleared Traditional

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl (K231029) - FDA 510(k) Clearance

Class I General Hospital device.

K231029 · Zhonghong Pulin Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
202d
Days
Class 1
Risk

K231029 is an FDA 510(k) clearance for the Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Zhonghong Pulin Medical Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on October 30, 2023 after a review of 202 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhonghong Pulin Medical Products Co., Ltd. devices

Submission Details

510(k) Number K231029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2023
Decision Date October 30, 2023
Days to Decision 202 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
73d slower than avg
Panel avg: 129d · This submission: 202d
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 Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K231029.
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
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232461 · Kossan International Sdn Bhd · Nov 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232266 · Better Care Plastic Technology Co., Ltd. · Nov 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
K230662 · Zhonghong Pulin Medical Products Co., Ltd. · Oct 2023
Nitrile Examination Gloves, Dual Color Black-Blue
K232550 · Shanxi Hongjin Plastic Technology Co., Ltd. · Oct 2023
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
K232070 · Better Care Plastic Technology Co., Ltd. · Oct 2023