BIONEX
- Primary DI
- 20860011725408
- Company
- Medzah Industries
- Model
- BNMD04
- Device description
- BIONEX Biodegradable Nitrile Powder Free Exam Gloves, Violet Blue, 9.5in, Finger 4.0mil, Palm 3.0mil, Textured Fingertip, Chemo and Fentanyl Approved, Large, 200ea/bx, 10bx/cs
- Published
- 2025-07-30
- 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
- true
Regulatory Flags
- DUNS number
- 114193536
- Device count
- 200
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20860011725408 | Package | GS1 | 10 | In Commercial Distribution |
| 10860011725401 | Primary | GS1 | 0 | |
| 00860011725404 | Unit of Use | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 20860011725408 | Package | GS1 | 10 | | 10860011725401 | | In Commercial Distribution |
| 10860011725401 | Primary | GS1 | 0 | | | | |
| 00860011725404 | Unit of Use | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| LZA | Polymer Patient Examination Glove | 1 | General Hospital | 880.6250 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| 860-288-8696 | info@medzah.com |
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