Product code IWP— Radiology

“A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -”

FDA has cleared 5 devices under product code IWP between 1985 and 1992, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19921 clearance
• 19911 clearance
• 19902 clearances
• 19851 clearance

• Hpi, Inc.2 clearances
• Infab Corp.1 clearance
• Burkhart Roentgen Intl., Inc.1 clearance
• Boots-Celltech Diagnostics, Inc.1 clearance

• K920538 — PROTECTIVE RADIOGRAFIC GLOVEBurkhart Roentgen Intl., Inc.·1992-05-29
• K904878 — SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.Hpi, Inc.·1991-03-07
• K905086 — HPI TRI-RADS VINYL RADIATION PROTECTION GLOVESHpi, Inc.·1990-12-03
• K900972 — RADIATION PROTECTION GLOVESInfab Corp.·1990-05-01
• K844683 — IMAGEN CHLAMYDIA TESTBoots-Celltech Diagnostics, Inc.·1985-02-06