FDA 510(k) clearance · back to tracker

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

Zibo Shengkun Chemical Industry Co., Ltd. cleared K250496 on 2025-07-07, decision: substantially equivalent

K-number

K250496

Sponsor

Zibo Shengkun Chemical Industry Co., Ltd.

Device

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-07-07

Product code

LZA

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K250496on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.