Cleared Traditional

K231643 - Biodegradable Nitrile Powder Free Exami...

K231643 is an FDA 510(k) clearance for Biodegradable Nitrile Powder Free Exami..., manufactured by Syntex Healthcare 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 95-day FDA review.

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

FDA 510(k) Submission Details - K231643

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.

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 682
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