Anaerobic Box Glove

Device Code: 3360

Product Code(s): JTM

Device Classification Information

Device Type ID3360
Device NameAnaerobic Box Glove
Regulation DescriptionAnaerobic Chamber.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.2120 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJTM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3360
DeviceAnaerobic Box Glove
Product CodeJTM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAnaerobic Chamber.
CFR Regulation Number866.2120 [🔎]
TPLC Last Update: 2019-04-02 20:28:11

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