FDA 510(k) clearance · back to tracker

Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.

Pt. Medisafe Technologies cleared K142941 on 2015-11-02, decision: substantially equivalent

K-number

K142941

Sponsor

Pt. Medisafe Technologies

Device

Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.

Class

Class I

Decision

Substantially Equivalent

Decision date

2015-11-02

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K142941on 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.