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

Surgeon's Gloves

Molnlycke Health Care, US LLC

The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for 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.

Pre-market Notification Details

Device IDK191869
510k NumberK191869
Device Name: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
ClassificationSurgeon's Gloves
Applicant Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross,  GA  30092
ContactLeonard Stewart
CorrespondentLeonard Stewart
Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross,  GA  30092
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-12
Decision Date2020-03-13

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