Last synced on 27 June 2025 at 11:06 pm

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190466
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/26/2019
Days to Decision
212 days
Submission Type
Statement

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190466
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/26/2019
Days to Decision
212 days
Submission Type
Statement