FDA 510(k) clearance · back to tracker

Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Ansell Healthcare Products, LLC cleared K190018 on 2019-05-23, decision: substantially equivalent

K-number

K190018

Sponsor

Ansell Healthcare Products, LLC

Device

Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Class

Class I

Decision

Substantially Equivalent

Decision date

2019-05-23

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K190018on 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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Source

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