FDA UDI
In Commercial Distribution
🇺🇸 United States
Posi-Prene Edge Pink
DI: 00850006162536
·
Model: P3400PF/S
·
Clinical Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Posi-Prene Edge Pink
- Primary DI
- 00850006162536
- Version / Model
- P3400PF/S
- Company Name
- Clinical Supply Company
- Labeler DUNS
- 620679308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- b9b3cc60-3be2-4f58-80c7-d89d3c29ee27
Device Description
P3400PF/S, Posi-Prene Edge Pink, 4 Gram, C.R., Pink, Powder Free, Examination Glove, Size Small, 100/Box
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
- Yes
- 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 |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56288 | Polychloroprene examination/treatment glove, non-powdered | A device made of polychloroprene (neoprene) 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/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 | 00850006162369 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00850006162536 | GS1 |
Customer Contacts
- Phone
- 1-800-468-0188
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Small |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 100 Degrees Fahrenheit