FDA UDI
In Commercial Distribution
🇺🇸 United States
LUXSPA Small nitrile disposable exam gloves
DI: 00860009297722
·
Model: 0003
·
Beltway Nail Supply, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LUXSPA Small nitrile disposable exam gloves
- Primary DI
- 00860009297722
- Version / Model
- 0003
- Company Name
- Beltway Nail Supply, LLC
- Labeler DUNS
- 068047800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-21
- Public Version
- 1
- Public Version Date
- 2022-11-29
- Public Version Status
- New
- Public Device Record Key
- 8704ae7b-92a6-427b-8752-b97a1e9b6e22
Device Description
Size Small. Single use nitrile disposable exam gloves.
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 |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56287 | Nitrile examination/treatment glove, powdered | 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 covered with powder to facilitate donning/removal; 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009297722 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110981 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 100 Degrees Fahrenheit