FDA UDI
In Commercial Distribution
🇺🇸 United States
AmerCareRoyal Sensi-Flex Powder-Free PVC Exam Gloves
DI: 00842312128481
·
Model: VINFRXLCPK
·
Amercareroyal, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AmerCareRoyal Sensi-Flex Powder-Free PVC Exam Gloves
- Primary DI
- 00842312128481
- Version / Model
- VINFRXLCPK
- Company Name
- Amercareroyal, LLC
- Labeler DUNS
- 002326965
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 1
- Public Version Date
- 2022-12-09
- Public Version Status
- New
- Public Device Record Key
- 215debbb-9dde-4901-a392-25512bca89cc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47176 | Vinyl examination/treatment glove, non-powdered | A non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842312128474 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00842312128481 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100339 | 000 |