FDA UDI
In Commercial Distribution
🇺🇸 United States
MocareHealth
DI: 06930518036854
·
Model: 723580
·
Shanghai Motex Healthcare Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MocareHealth
- Primary DI
- 06930518036854
- Version / Model
- 723580
- Company Name
- Shanghai Motex Healthcare Co.,Ltd.
- Labeler DUNS
- 530438738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-03
- Public Version
- 2
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- 861790e3-2b2e-4045-8ada-6242c9c8607c
Device Description
Nitrile Medical Examination Gloves, powder-free, latex-free, blue color, ambidextrous, beaded cuff, textured surface in the grip area, non-sterile.
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
- 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
- No
- Has Manufacturing Date
- No
- 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 |
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 |
|---|---|---|---|---|---|---|
| Package | 36930518036855 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 06930518036854 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030207 | 000 |