Cleared Abbreviated

ComfortPro Blue Nitrile Examination Gloves Powder Free (K212850) - FDA 510(k) Clearance

Class I General Hospital device.

K212850 · Thai Rubber Industry Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
94d
Days
Class 1
Risk

K212850 is an FDA 510(k) clearance for the ComfortPro Blue Nitrile Examination Gloves Powder Free. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Thai Rubber Industry Company Limited (Pluakdaeng, TH). The FDA issued a Cleared decision on December 10, 2021 after a review of 94 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Thai Rubber Industry Company Limited devices

Submission Details

510(k) Number K212850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2021
Decision Date December 10, 2021
Days to Decision 94 days
Submission Type Abbreviated
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
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Standards-based clearance path.

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

Liberty Management Group , Ltd.
Manoj Zacharias

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 K212850.
Iconic Nitrile Glove
K212182 · Iconic Medicare Sdn Bhd · Dec 2021
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Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
K212349 · Medi Legion Sdn.Bhd · Dec 2021
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K212922 · Hsk Medical Apparatus Foshan China Co., Ltd. · Dec 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · Anhui Xinyisheng Medical Technology Co.,Ltd · Dec 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535 · Mah Sing Healthcare Sdn. Bhd. · Dec 2021