Cleared Traditional

Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K183441) - FDA 510(k) Clearance

Class I General Hospital device.

K183441 · Semperit Investments Asia Pte , Ltd. · General Hospital
Download Printable Device Report (PDF)
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Oct 2019
Decision
296d
Days
Class 1
Risk

K183441 is an FDA 510(k) clearance for the Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Lo.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Semperit Investments Asia Pte , Ltd. (Singapore Central, SG). The FDA issued a Cleared decision on October 4, 2019 after a review of 296 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 Semperit Investments Asia Pte , Ltd. devices

Submission Details

510(k) Number K183441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2018
Decision Date October 04, 2019
Days to Decision 296 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
167d slower than avg
Panel avg: 129d · This submission: 296d
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

Mansour Consulting, LLC
Jay Mansour

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 496
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K183441.
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PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
K190466 · Shen Wei (Usa), Inc. · Sep 2019
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
K191800 · Kossan International Sdn Bhd · Sep 2019