Cleared Traditional

K230314 - Sterile Powder Free Nitrile Examination...

K230314 is an FDA 510(k) clearance for Sterile Powder Free Nitrile Examination..., manufactured by New Era Medicare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K230314 · New Era Medicare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
191d
Days
Class 1
Risk

K230314 is an FDA 510(k) clearance for the Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by New Era Medicare Sdn. Bhd. (Teluk Intan, MY). The FDA issued a Cleared decision on August 16, 2023 after a review of 191 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 New Era Medicare Sdn. Bhd. devices

FDA 510(k) Submission Details - K230314

510(k) Number K230314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2023
Decision Date August 16, 2023
Days to Decision 191 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 129d · This submission: 191d
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 K230314.
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
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · Shandong Intco Medical Products Co, Ltd. · Aug 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439 · S&S Glove Corporation · Aug 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232039 · Grand Work Plastic Products Co., Ltd. · Aug 2023