Last synced on 4 July 2025 at 11:05 pm

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213142
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/28/2022
Days to Decision
123 days
Submission Type
Statement

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213142
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/28/2022
Days to Decision
123 days
Submission Type
Statement