Cleared Traditional

Disposable Medical Nitrile Examination Gloves (non-sterile) (K212029) - FDA 510(k) Clearance

Class I General Hospital device.

K212029 · Taizhou Kangjian Medical Equipments Co., Ltd. · General Hospital
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Nov 2021
Decision
140d
Days
Class 1
Risk

K212029 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves (non-sterile). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Taizhou Kangjian Medical Equipments Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on November 16, 2021 after a review of 140 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 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 Taizhou Kangjian Medical Equipments Co., Ltd. devices

Submission Details

510(k) Number K212029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2021
Decision Date November 16, 2021
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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

Cytech (Shenzhen) Enterprise Management Consulting Co., Ltd.
Helen Nan

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 K212029.
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