Cleared Traditional

K103770 - SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (FDA 510(k) Clearance)

Class I General Hospital device.

K103770 · Syntex Healthcare Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
115d
Days
Class 1
Risk

K103770 is an FDA 510(k) clearance for the SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Syntex Healthcare Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on April 21, 2011 after a review of 115 days - within the typical 510(k) review window.

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 Syntex Healthcare Products Co., Ltd. devices

Submission Details

510(k) Number K103770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date April 21, 2011
Days to Decision 115 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
13d faster than avg
Panel avg: 128d · This submission: 115d
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 Peers - LZA Polymer Patient Examination Glove

All 1167
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K103770.
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