Cleared Traditional

K061756 - TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP

K061756 is an FDA 510(k) clearance for TEXTURED POWDER FREE NITRILE EXAM GLOVE..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K061756 · Shen Wei (Usa), Inc. · General Hospital
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Apr 2007
Decision
302d
Days
Class 1
Risk

K061756 is an FDA 510(k) clearance for the TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on April 19, 2007 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K061756

510(k) Number K061756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2006
Decision Date April 19, 2007
Days to Decision 302 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
173d slower than avg
Panel avg: 129d · This submission: 302d
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 1018
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K061756.
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
K071910 · Hartalega Sdn Bhd · Sep 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)
K071119 · Gx Corporation Sdn Bhd · Jul 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639 · Siam Sempermed Corp., Ltd. · Jun 2007
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K070097 · Gx Corporation Sdn Bhd · Mar 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919 · Shen Wei (Usa), Inc. · Mar 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K063627 · Smart Glove Corp. Sdn Bhd · Mar 2007