FDA 510(k) clearance · back to tracker

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

Ansell Healthcare Products, LLC cleared K182948 on 2019-03-22, decision: substantially equivalent

K-number

K182948

Sponsor

Ansell Healthcare Products, LLC

Device

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

Class

Class I

Decision

Substantially Equivalent

Decision date

2019-03-22

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K182948on 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.