FDA product code IWP: Radiographic Protective Glove
IWP is the FDA product code for radiographic protective glove. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 5 510(k) submissions under IWP, from 4 different applicants. The average 510(k) review took 78 days (median 68).
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. -
Classification
| Field | Value |
|---|---|
| Device name | Radiographic Protective Glove |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWP clearance
Top IWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hpi, Inc. | 2 | 1991-03-07 |
| Burkhart Roentgen Intl., Inc. | 1 | 1992-05-29 |
| Infab Corp. | 1 | 1990-05-01 |
| Boots-Celltech Diagnostics, Inc. | 1 | 1985-02-06 |
Most recent IWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920538 | Burkhart Roentgen Intl., Inc. | PROTECTIVE RADIOGRAFIC GLOVE | 1992-05-29 | 114 |
| K904878 | Hpi, Inc. | SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. | 1991-03-07 | 128 |
| K905086 | Hpi, Inc. | HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES | 1990-12-03 | 19 |
| K900972 | Infab Corp. | RADIATION PROTECTION GLOVES | 1990-05-01 | 60 |
| K844683 | Boots-Celltech Diagnostics, Inc. | IMAGEN CHLAMYDIA TEST | 1985-02-06 | 68 |
Recalls for IWP devices
openFDA lists no recalls for product code IWP.
Frequently asked questions
What is FDA product code IWP?
IWP is the FDA product code for radiographic protective glove. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWP?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWP?
Across 5 cleared submissions the average was 78 days from receipt to decision (median 68).
Which companies have the most IWP clearances?
Hpi, Inc. (2); Burkhart Roentgen Intl., Inc. (1); Infab Corp. (1); Boots-Celltech Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWP
- Run a recall and safety report across every IWP manufacturer
- Watch product code IWP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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