PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate— 510(k) K190466
Substantially EquivalentShen Wei USA, Inc.
FDA 510(k) clearance K190466 for PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate, Substantially Equivalent on 2019-09-26. Applicant: Shen Wei USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei USA, Inc.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union City, CA, US
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Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.