Sterile Nitrile Examination Glove
- Primary DI
- 00616784652412
- Brand
- Sterile Nitrile Examination Glove
- Company
- DYNAREX CORPORATION
- Model
- 6524
- Device description
- Sterile Nitrile Examination Glove, Cuffed and Powder-Free, Ambidextrous, 1 Glove per Package, Large
- Published
- 2022-04-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| LZA | Polymer Patient Examination Glove |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784652429 | Package | GS1 | 100 | In Commercial Distribution |
| 00616784652436 | Package | GS1 | 8 | In Commercial Distribution |
| 00616784652412 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Nitrile examination/treatment glove, non-powdered, non-antimicrobial | A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
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