Cleared Traditional

Powder Free Nitrile Patient Examination Gloves, Blue Color (K211864) - FDA 510(k) Clearance

Class I General Hospital device.

K211864 · Siyang Jaysun Medtech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
219d
Days
Class 1
Risk

K211864 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Gloves, Blue Color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siyang Jaysun Medtech Co., Ltd. (Suqian, CN). The FDA issued a Cleared decision on January 21, 2022 after a review of 219 days - an extended review 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: 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 Siyang Jaysun Medtech Co., Ltd. devices

Submission Details

510(k) Number K211864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2021
Decision Date January 21, 2022
Days to Decision 219 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
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

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

Beijing Easy-Link Company
Chu Xiaoan

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.

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All 489
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