Identity
- Trade Name
- Black Pearl Nitrile FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Black nitrile gloves - medical grade - size Extra Small FDA UDI
- Model / Reference
- GP0031 FDA UDI
- Description
- Black nitrile gloves - medical grade - size Extra Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00721573000418 FDA UDI
- 510(k) Number
- K182528 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Black Pearl Nitrile by Ug Healthcare (usa), Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182528 also covers:
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
- AMERICAN PROTECTIVE PRODUCTS — American Protective Products LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ug Healthcare (usa), Inc.
Sources (1)
- FDA UDI d71cbdfe-b00d-41dd-be0c-2fa2347ca5c2 34 fields · synced May 30, 2026