US Medical Glove
- Primary DI
- 00850060649141
- Brand
- US Medical Glove
- Company
- US Medical Glove Company L.L.C.
- Model
- Blue Large
- Catalog number
- 1003-10
- Device description
- Nitrile Exam Gloves (Chemotherapy Drug Tested) 5MIL BLUE FDA 510(k) K223748 Size: Large Large Master Carton
- Published
- 2024-01-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| LZA | Polymer Patient Examination Glove |
| LZC | Medical Glove, Specialty |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 1 |
| LZC | Medical Glove, Specialty | General Hospital | 1 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K223748 | 000 | Nitrile Exam Gloves (Chemotherapy Drug Tested) | Us Medical Glove Company, LLC | 2023-01-13 | LZA |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850060649158 | Primary | GS1 | 0 | |
| 00850060649165 | Primary | GS1 | 0 | |
| 00850060649141 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850060649158 | 00850060649158 | 850060649158 | 0850060649158 |
| 00850060649165 | 00850060649165 | 850060649165 | 0850060649165 |
| 00850060649141 | 00850060649141 | 850060649141 | 0850060649141 |
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. |
Regulatory Flags
- DUNS number
- 117764502
- Device count
- 1000
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00850060649080 | US Medical Glove | Blue Small | 1001-10 | 2024-01-17 |
| 00850060649110 | US Medical Glove | Blue Medium | 1002-10 | 2024-01-17 |
| 00850060649172 | US Medical Glove | Blue Extra Large | 1004-10 | 2024-01-17 |
Other Devices Sharing Product Codes
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