Identity
- Trade Name
- FifthPulse FDA UDI
- Generic Name
- Nitrile surgical glove, non-powdered FDA UDI
- Device Name
- Medical Examination Nitrile Gloves FDA UDI
- Model / Reference
- Fuchsia - M FDA UDI
- Description
- Medical Examination Nitrile Gloves FDA UDI
Identifiers
- Catalog Number
- FMN100345 FDA UDI
- Primary DI / UDI-DI
- 00810084934913 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile surgical glove, non-powdered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile surgical glove, non-powdered
FifthPulse by Jeg & Sons Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile surgical glove, non-powdered.
- CORRECT TOUCH — Ct International · Class I
- CORRECT TOUCH — Ct International · Class I
- CORRECT TOUCH — Ct International · Class I
- Nephron Nitrile — Nephron Nitrile LLC · Class I
- P&P Medical Surgical LLC — P&P Medical Surgical LLC · Class I
- PHARMA-GLOVE-LTC — McGowan Enterprises, Inc. · Class I
- P&P Medical Surgical LLC — P&P Medical Surgical LLC · Class I
- Virtue — Nephron Nitrile LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jeg & Sons Inc.
Sources (1)
- FDA UDI 3b952495-43d9-451b-9e8e-4932333637b8 34 fields · synced May 31, 2026