Cleared Traditional

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K231643) - FDA 510(k) Clearance

Class I General Hospital device.

K231643 · Syntex Healthcare Products Co., Ltd. · General Hospital
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Sep 2023
Decision
95d
Days
Class 1
Risk

K231643 is an FDA 510(k) clearance for the Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chem.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Syntex Healthcare Products Co., Ltd. (Xinji, CN). The FDA issued a Cleared decision on September 8, 2023 after a review of 95 days - within the typical 510(k) review window.

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 Syntex Healthcare Products Co., Ltd. devices

Submission Details

510(k) Number K231643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2023
Decision Date September 08, 2023
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 K231643.
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
K232064 · Isikel Manufacturing, LLC · Oct 2023
Chemotherapy Gloves
K230847 · 3A Glove Sdn. Bhd. · Sep 2023
Powder-Free Nitrile Examination Gloves
K223214 · Global Protection Corp. · Sep 2023
Powder Free Nitrile Examination Gloves (Black)
K232353 · Shanxi Hongjin Plastic Technology Co., Ltd. · Aug 2023
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K231435 · Kimberly Clark Corporation · Aug 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103 · Shandong Yinghng Medical Products Co., Ltd. · Aug 2023