BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES— 510(k) K140477

Clearance details

Applicant

Molnlycke Health Care Us, LLC

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2014-02-26

Decision date

2015-03-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Norcross, GA, 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

• K232508 — Barrier EasyWarm Active Self-Warming Blanket2023-09-15
• K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System2021-07-01
• K202090 — Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim2020-11-22
• K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro2020-04-10
• K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim2020-03-13