Cream, Gloving, Surgeon's

Device Code: 2823

Product Code(s): KGQ

Device Classification Information

Device Type ID2823
Device NameCream, Gloving, Surgeon's
Regulation DescriptionSurgeon's Gloving Cream.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4470 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKGQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2823
DeviceCream, Gloving, Surgeon's
Product CodeKGQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgeon's Gloving Cream.
CFR Regulation Number878.4470 [🔎]
TPLC Last Update: 2019-04-02 20:19:20

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