Cleared Traditional

Disposable Medical Nitrile Examination Gloves (Model:XYS-001) (K213371) - FDA 510(k) Clearance

Class I General Hospital device.

K213371 · Anhui Xinyisheng Medical Technology Co.,Ltd · General Hospital
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Dec 2021
Decision
58d
Days
Class 1
Risk

K213371 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves (Model:XYS-001). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Anhui Xinyisheng Medical Technology Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on December 9, 2021 after a review of 58 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 Anhui Xinyisheng Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K213371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2021
Decision Date December 09, 2021
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 K213371.
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
K212349 · Medi Legion Sdn.Bhd · Dec 2021
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850 · Thai Rubber Industry Company Limited · Dec 2021
Nitrile Examination Gloves
K212922 · Hsk Medical Apparatus Foshan China Co., Ltd. · Dec 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535 · Mah Sing Healthcare Sdn. Bhd. · Dec 2021
Nitrile disposable examination gloves
K212578 · Xingyu Medical Tech Co., Ltd. · Dec 2021
powder free nitrile examination glove - white, non-sterile
K212802 · Hong Seng Gloves Sdn Bhd · Dec 2021

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.