FLOW MEDICAL X-RAY PROTECTIVE GLOVES

Shield, Protective, Personnel

FLOW X-RAY CORP.

The following data is part of a premarket notification filed by Flow X-ray Corp. with the FDA for Flow Medical X-ray Protective Gloves.

Pre-market Notification Details

• Device ID: K791522
• 510k Number: K791522
• Device Name: FLOW MEDICAL X-RAY PROTECTIVE GLOVES
• Classification: Shield, Protective, Personnel
• Applicant: FLOW X-RAY CORP. 55 NORTHEREN BLVD., SUITE 200 Great Neck, NY 11021
• Product Code: KPY
• CFR Regulation Number: 892.6500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-08-10
• Decision Date: 1979-10-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00843696152420	K791522	000