510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IWPClass I

Radiographic Protective Glove

21 CFR 892.6500 / Radiology
FDA source (opens on fda.gov)

IWP is the FDA product code for Radiographic Protective Glove, a class I device type, regulated under 21 CFR 892.6500. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWP
Device name
Radiographic Protective Glove
FDA definition
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. -
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code IWP

By decision year
5 clearances under product code IWP with a decision year between 1985 and 1992, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IWP by decision year
YearClearances
19851
19902
19911
19921

Applicants with the most clearances

Product code IWP
Applicants holding the most 510(k) clearances under product code IWP
ApplicantClearances
Hpi, Inc.2
Boots-Celltech Diagnostics, Inc.1
Burkhart Roentgen Intl., Inc.1
Infab, LLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order