Home / 510(k) Clearances / K202090

510(k) 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 by Molnlycke Health Care Us, LLC — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2020
Date Received
July 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgeon'S Gloves
Device Class
Class I
Regulation Number
878.4460
Review Panel
HO
Submission Type

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

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  • K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Under (May 24, 2019)
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Other clearances for product code KGO

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  • K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drug (December 20, 2023)
  • K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX P (October 20, 2023)
  • K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (September 29, 2023)
  • K231446 — Single-Use Latex Sterile Surgical Gloves (SG100) (September 22, 2023)
  • K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with (August 31, 2023)
  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green (August 18, 2023)