Cleared Traditional

BIOTECH Nitrile Examination Gloves (K202419) - FDA 510(k) Clearance

Class I General Hospital device.

K202419 · Tk Hitech Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
235d
Days
Class 1
Risk

K202419 is an FDA 510(k) clearance for the BIOTECH Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tk Hitech Technology Co., Ltd. (Tha Rang, Bangkok, TH). The FDA issued a Cleared decision on April 16, 2021 after a review of 235 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 Tk Hitech Technology Co., Ltd. devices

Submission Details

510(k) Number K202419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2020
Decision Date April 16, 2021
Days to Decision 235 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
106d slower than avg
Panel avg: 129d · This submission: 235d
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

Provision Consulting Group, Inc.
Joyce Kwon

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 K202419.
Powder Free Blue Nitrile Examination Glove
K203512 · Vip Glove Sdn Bhd · Apr 2021
Nitrile Glove Powder Free Blue
K210145 · Changzhou Universal Medical Equipment Co., Ltd. · Apr 2021
Disposable Nitrile Examination Gloves
K203805 · Jiangsu Yanfang Medical Technology Co., Ltd. · Apr 2021
Disposable Nitrile Gloves
K210276 · Fujian Ercon Medical Management Co., Ltd. · Apr 2021
Nitrile Examination Gloves
K210106 · Zhenjiang Huayang Latex Products Co., Ltd. · Apr 2021
Blue Nitrile Exam Glove, Powder Free
K210057 · Real Star Medical Technology Co., Ltd. · Mar 2021