Lead Mittens
- Primary DI
- G031101MITRL0
- Brand
- Lead Mittens
- Company
- Shielding International Inc.
- Model
- 101MITRL
- Device description
- Lead mittens - 15" one piece dip molded
- Published
- 2023-08-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IWP | Radiographic Protective Glove |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IWP | Radiographic Protective Glove | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G031101MITRL0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Radiation-shielding procedure preparation glove/mitten | A personal protective device intended to be used to shield the entire hand or hands of medical personnel from unnecessary exposure to primary and scattered radiation associated with the preparation of a diagnostic and/or therapeutic radiological procedure (e.g., patient positioning). It is typically intended for procedure set-up or patient positioning; it is not a patient examination/treatment glove, nor a surgical glove. It typically includes a thin layer of lead (Pb) or lead-equivalent material and may be fluid resistant. |
Regulatory Flags
- DUNS number
- 009647322
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| G031WABRX2XFLF0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFLF | | 2023-10-17 |
| G031WABRX2XFLFL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFLFL | | 2023-10-17 |
| G031WABRX2XFNL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFNL | | 2023-10-17 |
| G031WABRX2XFNLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFNLL | | 2023-10-17 |
| G031WABRX2XFRL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFRL | | 2023-10-17 |
| G031WABRX2XFRLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFRLL | | 2023-10-17 |
| G031WABRX2XFTL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFTL | | 2023-10-17 |
| G031WABRX2XFTLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XFTLL | | 2023-10-17 |
| G031WABRX2XMLF0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMLF | | 2023-10-17 |
| G031WABRX2XMLFL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMLFL | | 2023-10-17 |
| G031WABRX2XMNL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMNL | | 2023-10-17 |
| G031WABRX2XMNLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMNLL | | 2023-10-17 |
| G031WABRX2XMRL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMRL | | 2023-10-17 |
| G031WABRX2XMRLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMRLL | | 2023-10-17 |
| G031WABRX2XMTL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMTL | | 2023-10-17 |
| G031WABRX2XMTLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRX2XMTLL | | 2023-10-17 |
| G031WABRXMFLF0 | Wrap Around Back Relief Apron - BRX Belt | WABRXMFLF | | 2023-10-17 |
| G031WABRXMFLFL0 | Wrap Around Back Relief Apron - BRX Belt | WABRXMFLFL | | 2023-10-17 |
| G031WABRXMFNL0 | Wrap Around Back Relief Apron - BRX Belt | WABRXMFNL | | 2023-10-17 |
| G031WABRXMFNLL0 | Wrap Around Back Relief Apron - BRX Belt | WABRXMFNLL | | 2023-10-17 |
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