Cleared Traditional

K133168 - DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE

K133168 is an FDA 510(k) clearance for DERMAGRIP POWDER FREE BLUE NITRILE PATI..., manufactured by Wrp Asia Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K133168 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
294d
Days
Class 1
Risk

K133168 is an FDA 510(k) clearance for the DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on August 7, 2014 after a review of 294 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 Wrp Asia Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K133168

510(k) Number K133168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date August 07, 2014
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K133168.
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141590 · Eco Medi Glove Sdn. Bhd. · Sep 2014
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
K141021 · Hl Rubber Industries Sdn Bhd · Aug 2014
BLUE NITRILE POWDER FREE EXAM GLOVES
K133325 · Shandong Xinshi Medical Products Co., Ltd. · 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 GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
K133699 · Pt. Smartglove Indonesia · Jul 2014
EXAMINATION GLOVES
K140316 · Hl Rubber Industries Sdn Bhd · Jul 2014