Cleared Traditional

K211667 - Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K211667 · Changzhou Universal Medical Equipment Co., Ltd. · General & Plastic Surgery device
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Sep 2021
Decision
114d
Days
Class 1
Risk

K211667 is an FDA 510(k) clearance for the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). Classified as N-acetylprocainamide Control Materials (product code LAZ), Class I - General Controls.

Submitted by Changzhou Universal Medical Equipment Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 23, 2021 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 862.3280 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Changzhou Universal Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K211667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date September 23, 2021
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 114d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAZ N-acetylprocainamide Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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

Cnmed Consultant
Johnson Liu

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.