FDA UDI
In Commercial Distribution
🇺🇸 United States
Xpect
DI: 00850047958990
·
Model: 182309
·
Cintas Corporation No. 2
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8
Basic Information
- Brand Name
- Xpect
- Primary DI
- 00850047958990
- Version / Model
- 182309
- Company Name
- Cintas Corporation No. 2
- Labeler DUNS
- 118376317
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2023-11-03
- Public Version
- 1
- Public Version Date
- 2023-11-13
- Public Version Status
- New
- Public Device Record Key
- 5142eba7-fdf3-400e-ba35-137d1d0e385c
Device Description
Polymer Patient Exam Gloves Large
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 61938 | Surgical/examination garment kit | A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10850047958997 | GS1 | ||||
| Primary | 00850047958990 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121526 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store above 100 F (38 C)