FDA 510(k) clearance · back to tracker

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Lingshi Hongruida Health Protection Technology Co., Ltd. cleared K243959 on 2025-02-24, decision: substantially equivalent

K-number

K243959

Sponsor

Lingshi Hongruida Health Protection Technology Co., Ltd.

Device

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-02-24

Product code

LZC

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K243959on 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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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.