Cleared Traditional

K220155 - Powder-free Nitrile Examination Gloves ...

K220155 is an FDA 510(k) clearance for Powder-free Nitrile Examination Gloves ..., manufactured by Motex Healthcare (Anhui) Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K220155 · Motex Healthcare (Anhui) Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2022
Decision
124d
Days
Class 1
Risk

K220155 is an FDA 510(k) clearance for the Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Motex Healthcare (Anhui) Co., Ltd. (Xuancheng City, CN). The FDA issued a Cleared decision on May 23, 2022 after a review of 124 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 Motex Healthcare (Anhui) Co., Ltd. devices

FDA 510(k) Submission Details - K220155

510(k) Number K220155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2022
Decision Date May 23, 2022
Days to Decision 124 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
5d faster than avg
Panel avg: 129d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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

Roc Chinese-European Industrial Research Society
Jen Ke-Min

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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K220155.
PP Care Nitrile Examination Gloves
K212629 · Eg Group Product and Services Co., Ltd. · May 2022
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K211810 · Pt. Shamrock Manufacturing Corpora · May 2022
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K220429 · One Glove Industrial Sdn Bhd · May 2022