Cleared Traditional

K203512 - Powder Free Blue Nitrile Examination Glove

K203512 is an FDA 510(k) clearance for Powder Free Blue Nitrile Examination Glove, manufactured by Vip Glove Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K203512 · Vip Glove Sdn Bhd · General Hospital
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Apr 2021
Decision
147d
Days
Class 1
Risk

K203512 is an FDA 510(k) clearance for the Powder Free Blue Nitrile Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Vip Glove Sdn Bhd (Beranang, MY). The FDA issued a Cleared decision on April 26, 2021 after a review of 147 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 Vip Glove Sdn Bhd devices

FDA 510(k) Submission Details - K203512

510(k) Number K203512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2020
Decision Date April 26, 2021
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 684
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K203512.
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · Meditech Gloves Sdn Bhd · May 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
K210944 · Harbour Health, LLC · Apr 2021
Disposable Nitrile Examination Gloves
K203436 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Apr 2021
Nitrile Glove Powder Free Blue
K210145 · Changzhou Universal Medical Equipment Co., Ltd. · Apr 2021
Disposable Nitrile Examination Gloves
K203805 · Jiangsu Yanfang Medical Technology Co., Ltd. · Apr 2021
BIOTECH Nitrile Examination Gloves
K202419 · Tk Hitech Technology Co., Ltd. · Apr 2021