Cleared Traditional

K133325 - BLUE NITRILE POWDER FREE EXAM GLOVES

K133325 is an FDA 510(k) clearance for BLUE NITRILE POWDER FREE EXAM GLOVES, manufactured by Shandong Xinshi Medical Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K133325 · Shandong Xinshi Medical Products Co., Ltd. · General Hospital
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Aug 2014
Decision
283d
Days
Class 1
Risk

K133325 is an FDA 510(k) clearance for the BLUE NITRILE POWDER FREE EXAM GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shandong Xinshi Medical Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on August 8, 2014 after a review of 283 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 Shandong Xinshi Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K133325

510(k) Number K133325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2013
Decision Date August 08, 2014
Days to Decision 283 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
154d slower than avg
Panel avg: 129d · This submission: 283d
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 750
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K133325.
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
K142283 · Yty Industry (Manjung) Sdn Bhd · Jan 2015
Nitrile Powder Free Examination Glove (Blue)
K142588 · Hartalega Sdn Bhd · Dec 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050 · Hartalega Sdn Bhd · Sep 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · Wrp Asia Pacific Sdn. Bhd. · Aug 2014
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
K140890 · Hartalega NGC Sdn. Bhd. · Jul 2014
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
K133689 · Pt. Medisafe Technologies · Jul 2014