SKINSENSE POLYISOPRENE UNDERGLOVE— 510(k) K081180
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K081180 for SKINSENSE POLYISOPRENE UNDERGLOVE, Substantially Equivalent on 2008-08-26. Applicant: Molnlycke Health Care Us, LLC. Device class: 1.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
Recent devices under product code KGO
view all- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K253060 — Sterile Latex Powder Free Surgical Gloves
- K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- K240790 — Polyisoprene Surgical gloves
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
More clearances from Molnlycke Health Care Us, LLC
view all- K232508 — Barrier EasyWarm Active Self-Warming Blanket
- K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System
- 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 Claim
- K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
- 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 Claim
Data sourced from openFDA. This site is unofficial and independent of the FDA.