Cleared Traditional

K093516 - NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES

K093516 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.

K093516 · Summit Glove, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
228d
Days
Class 1
Risk

K093516 is an FDA 510(k) clearance for the NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION .... 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 - K093516

510(k) Number K093516 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 1145
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K093516.
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
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NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
K100979 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Jul 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K101293 · Pt. Smartglove Indonesia · Jul 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
K093517 · Summit Glove, Inc. · Jun 2010
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092874 · Quality Gallant Sdn. Bhd. · Jun 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · La Glove (M) Sdn. Bhd. · Jun 2010