K202449

Substantially Equivalent

Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein

Applicant: Medline Industries, Inc.
Product code: KGO
Advisory panel: General, Plastic Surgery
Date received: 2020-08-26
Decision date: 2020-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.