IWP
5 FDA 510(k) clearances · Product code
68 daysmedian time to decision
128 days90th percentile
5clearances measured
FDA profile
- Official device name
- Radiographic Protective Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.6500
- Medical specialty
- Radiology
- 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. -
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PROTECTIVE RADIOGRAFIC GLOVE (K920538) | Burkhart Roentgen Intl., Inc. | 1992-05-29 |
| SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (K904878) | Hpi, Inc. | 1991-03-07 |
| HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (K905086) | Hpi, Inc. | 1990-12-03 |
| RADIATION PROTECTION GLOVES (K900972) | Infab Corp. | 1990-05-01 |
| IMAGEN CHLAMYDIA TEST (K844683) | Boots-Celltech Diagnostics, Inc. | 1985-02-06 |
Track IWP automatically
Every clearance here is in the API, with alerts when new ones post.