Cleared Traditional

K210330 - Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (FDA 510(k) Clearance)

Class I General Hospital device.

K210330 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
393d
Days
Class 1
Risk

K210330 is an FDA 510(k) clearance for the Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use wit.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on March 4, 2022 after a review of 393 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 Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K210330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2021
Decision Date March 04, 2022
Days to Decision 393 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
265d slower than avg
Panel avg: 128d · This submission: 393d
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 Consultant

Wrp USA, Inc.
Saravanan Ramasamy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1167
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