Cleared Traditional

Powder-Free Nitrile Examination Glove, Non-Sterile (K221877) - FDA 510(k) Clearance

Class I General Hospital device.

K221877 · Goodgloves Industries Sdn Bhd · General Hospital
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Jul 2022
Decision
25d
Days
Class 1
Risk

K221877 is an FDA 510(k) clearance for the Powder-Free Nitrile Examination Glove, Non-Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Goodgloves Industries Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on July 23, 2022 after a review of 25 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Goodgloves Industries Sdn Bhd devices

Submission Details

510(k) Number K221877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2022
Decision Date July 23, 2022
Days to Decision 25 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 K221877.
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
K221773 · Onetexx Sdn Bhd · Jul 2022
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K221269 · Better Care Plastic Technology Co., Ltd. · Jul 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221271 · Shandong Maida Medical Technology Co., Ltd. · Jul 2022
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
K220943 · Eco Medi Glove Sdn. Bhd. · Jul 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
K221229 · Zibo Blue Sail Health Technology Co., Ltd. · Jul 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574 · Grand Work Plastic Products Co., Ltd. · Jul 2022

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.