Cleared Traditional

K163035 - DilaCheck Nitrile Powder Free Examinati...

K163035 is an FDA 510(k) clearance for DilaCheck Nitrile Powder Free Examinati..., manufactured by Elm Tree Medical, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K163035 · Elm Tree Medical, Inc. · General Hospital
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Jul 2017
Decision
249d
Days
Class 1
Risk

K163035 is an FDA 510(k) clearance for the DilaCheck Nitrile Powder Free Examination Glove, (Sterile). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Elm Tree Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on July 7, 2017 after a review of 249 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 Elm Tree Medical, Inc. devices

FDA 510(k) Submission Details - K163035

510(k) Number K163035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date July 07, 2017
Days to Decision 249 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 129d · This submission: 249d
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 730
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K163035.
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104 · Yty Industry (Manjung) Sdn Bhd · Aug 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · Shen Wei (Usa), Inc. · Jul 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
K170686 · Brightway Holdings Sdn. Bhd. · Jul 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
K170794 · Hartalega NGC Sdn. Bhd. · Jun 2017
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
K170290 · Shen Wei (Usa), Inc. · May 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K162294 · Brightway Holdings Sdn. Bhd. · Apr 2017