Cleared Traditional

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K202003) - FDA 510(k) Clearance

Class I General Hospital device.

K202003 · Gmp Medicare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
219d
Days
Class 1
Risk

K202003 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemothera.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Gmp Medicare Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on February 24, 2021 after a review of 219 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 Gmp Medicare Sdn. Bhd. devices

Submission Details

510(k) Number K202003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2020
Decision Date February 24, 2021
Days to Decision 219 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
90d slower than avg
Panel avg: 129d · This submission: 219d
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

Tg Medical USA (Inc)
David Lim

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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K202003.
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
K202078 · Shen Wei (Usa), Inc. · Mar 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
K202356 · Kanglongda Vietnam Protection Technology Company Limited · Mar 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402 · Jiangsu Tianshuo Medical Products Co., Ltd. · Mar 2021
LYDUS Nitrile Examination Gloves, Powder Free
K203191 · Nathan Trading Co., Ltd. · Feb 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
K202622 · O&M Halyard, Inc. · Jan 2021
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384 · Hi-Care Thai Gloves Co. , Ltd. · Dec 2020