Basic NGPF201C4
by Intco Medical Industries, Inc.
Basic NGPF201C4 is a Class I device made by Intco Medical Industries, Inc., cleared under FDA 510(k) K233598 on 26 Jan 2024 and listed in FDA GUDID since 28 Sep 2024 (UDI-DI B845NGPF201C41), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB845NGPF201C41 | Date28 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233598 | Date26 Jan 2024 | StatusActive |
Official records
- FDA 510(k) database K233598
Across registries
- FDA 510(k) K233598 decided 26 Jan 2024 Active
- FDA GUDID UDI-DI B845NGPF201C41 listed 28 Sep 2024 Listed
Timeline
- Cleared FDA 510(k) K233598
- Listed FDA GUDID B845NGPF201C41
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Basic
- Generic name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Model / Ref / Catalog
- NGPF201C4
- Primary DI / UDI-DI
- B845NGPF201C41
- 510(k) Number
- FDA product code
- LZA, LZC, QDO, OPJ
- GMDN term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Device class
- Class I
- Regulation number
- 880.6250
- GUDID distribution status
- In Commercial Distribution
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