Cleared Traditional

K210463 - Thermoplastic Elastomer (TPE) Hybrid Examination Glove (FDA 510(k) Clearance)

Class I General Hospital device.

K210463 · Xuzhou Full Sun Medical Products , Ltd. · General Hospital
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Jan 2022
Decision
341d
Days
Class 1
Risk

K210463 is an FDA 510(k) clearance for the Thermoplastic Elastomer (TPE) Hybrid Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Xuzhou Full Sun Medical Products , Ltd. (Pizhou, CN). The FDA issued a Cleared decision on January 23, 2022 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Xuzhou Full Sun Medical Products , Ltd. devices

Submission Details

510(k) Number K210463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2021
Decision Date January 23, 2022
Days to Decision 341 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
213d slower than avg
Panel avg: 128d · This submission: 341d
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 Peers - LZA Polymer Patient Examination Glove

All 1167
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K210463.
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K252075 · Program Insite, LLC · Oct 2025
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K251716 · Basic Medical Technology, Inc. · Aug 2025