Cleared Traditional

K093517 - NITRITECH OR MULTIPLE PRIVATE LABEL NON...

K093517 is an FDA 510(k) clearance for NITRITECH OR MULTIPLE PRIVATE LABEL NON..., manufactured by Summit Glove, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K093517 · Summit Glove, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2010
Decision
228d
Days
Class 1
Risk

K093517 is an FDA 510(k) clearance for the NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT E.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Summit Glove, Inc. (Minerva, US). The FDA issued a Cleared decision on June 29, 2010 after a review of 228 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 Summit Glove, Inc. devices

FDA 510(k) Submission Details - K093517

510(k) Number K093517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date June 29, 2010
Days to Decision 228 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
99d slower than avg
Panel avg: 129d · This submission: 228d
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 683
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K093517.
NUGARD NITILE GREY COLOR
K102230 · Terang Nusa Sdn Bhd · Sep 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646 · Sgmp Co., Ltd. · Sep 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
MICRO-TOUCH NITRILE
K093523 · Ansell Healthcare Products, LLC · Mar 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K092411 · Shen Wei (Usa), Inc. · Oct 2009