FDA UDI
In Commercial Distribution
🇺🇸 United States
QUALATEX
DI: 09555697505068
·
Model: LEGPPS XS
·
TAN SIN LIAN INDUSTRIES SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUALATEX
- Primary DI
- 09555697505068
- Version / Model
- LEGPPS XS
- Catalog Number
- LEGPPS
- Company Name
- TAN SIN LIAN INDUSTRIES SDN. BHD.
- Labeler DUNS
- 596473983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-04
- Public Version
- 1
- Public Version Date
- 2023-07-12
- Public Version Status
- New
- Public Device Record Key
- 612e3935-0602-4d65-81ec-8f35bfeaac71
Device Description
Powdered Latex Examination Gloves Size XS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LYY | Latex Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47173 | Hevea-latex examination/treatment glove, powdered | A device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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 | 09555697505068 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992557 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius