Cleared Special

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution (K252117) - FDA 510(k) Clearance

Class I General Hospital device.

K252117 · Sw Technologies, Inc. · General Hospital
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Jun 2026
Decision
352d
Days
Class 1
Risk

K252117 is an FDA 510(k) clearance for the Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for u.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sw Technologies, Inc. (Union City, US). The FDA issued a Cleared decision on June 24, 2026 after a review of 352 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sw Technologies, Inc. devices

Submission Details

510(k) Number K252117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date June 24, 2026
Days to Decision 352 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 129d · This submission: 352d
Pathway characteristics
Modification to existing cleared device.

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 490
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K252117.
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
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K253160 · Basic Medical Technology, Inc. · Jan 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
K252549 · Kossan International Sdn Bhd · Jan 2026
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K251141 · Mercator Medical (Thailand), Ltd. · Nov 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
K250861 · Hartalega NGC Sdn. Bhd. · Oct 2025