Cleared Traditional

K222449 - Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) (FDA 510(k) Clearance)

Class I General Hospital device.

K222449 · Better Care Plastic Technology Co., Ltd. · General Hospital

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Optimized for regulatory review, auditing and printing

Aug 2022

Decision

12d

Days

Class 1

Risk

K222449 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drug.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on August 27, 2022 after a review of 12 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 Better Care Plastic Technology Co., Ltd. devices

Submission Details

510(k) Number	K222449 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 15, 2022
Decision Date	August 27, 2022
Days to Decision	12 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

116d faster than avg

Panel avg: 128d · This submission: 12d

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 Surgeons) 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

Hongray USA Medical Products, Inc.

Kathy 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.