DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES— 510(k) K071746

Clearance details

Applicant

Ansell Healthcare Products, LLC

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2007-06-27

Decision date

2007-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dothan, AL, US

• K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more2026-07-28
• K253060 — Sterile Latex Powder Free Surgical Gloves2026-05-22
• K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid2025-08-19
• K240790 — Polyisoprene Surgical gloves2024-08-23
• K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more2024-03-28

• K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential2023-08-23
• K213289 — Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs2023-05-26
• K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs2022-03-10
• K210401 — Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate2021-06-13
• K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for2020-06-19