FDA UDI
In Commercial Distribution
🇺🇸 United States
Black Talon
DI: 40842209133275
·
Model: ZZ-0274
·
NORTH AMERICAN RESCUE, LLC
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Black Talon
- Primary DI
- 40842209133275
- Version / Model
- ZZ-0274
- Catalog Number
- ZZ-0274
- Company Name
- NORTH AMERICAN RESCUE, LLC
- Labeler DUNS
- 832426782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2025-03-31
- Public Version
- 1
- Public Version Date
- 2025-04-08
- Public Version Status
- New
- Public Device Record Key
- 45916801-f73f-4702-ba43-f93a5b9bbb1c
Device Description
GLOVES, BLACK NITRILE - SMALL (1000 pack)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
| LZC | Medical Glove, Specialty | General Hospital | 880.6250 | 1 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | 880.6250 | 1 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56291 | Nitrile surgical glove, non-powdered | A sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10842209133274 | GS1 | ||||
| Primary | 40842209133275 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232654 | 000 |