FDA UDI
In Commercial Distribution
🇺🇸 United States
ORCARE SURGICAL LATEX PF
DI: 09551006061010
·
Model: 6.0
·
CAREGLOVE GLOBAL SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- ORCARE SURGICAL LATEX PF
- Primary DI
- 09551006061010
- Version / Model
- 6.0
- Company Name
- CAREGLOVE GLOBAL SDN. BHD.
- Labeler DUNS
- 865779649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-12-29
- Public Version
- 1
- Public Version Date
- 2024-01-08
- Public Version Status
- New
- Public Device Record Key
- 68032a26-f68a-4ff3-97cd-1fb773dd0ca6
Device Description
Sterile Latex Surgical Gloves, Powder Free
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGO | Surgeon'S Gloves | General, Plastic Surgery | 878.4460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63217 | Hevea-latex examination/treatment glove, non-powdered, antimicrobial | 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09551006061041 | GS1 | Carton | 4 | In Commercial Distribution | |
| Primary | 09551006061010 | GS1 | ||||
| Unit of Use | 09551006061478 | GS1 |
Customer Contacts
- Phone
- +6067292130
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190241 | 000 |