Cleared Traditional

K213325 - Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K213325 · Anhui Xinyisheng Medical Technology Co.,Ltd · General Hospital
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Jan 2022
Decision
115d
Days
Class 1
Risk

K213325 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemothera.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Anhui Xinyisheng Medical Technology Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on January 28, 2022 after a review of 115 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 Anhui Xinyisheng Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K213325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2021
Decision Date January 28, 2022
Days to Decision 115 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
13d faster than avg
Panel avg: 128d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 Consulting
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.

Regulatory Peers - LZC Medical Glove, Specialty

All 78
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K213325.
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K220491 · Hainan Asther Medical Equipment Co., Ltd. · May 2022