Last synced on 27 June 2025 at 11:06 pm

Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, 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
K213141
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/28/2022
Days to Decision
243 days
Submission Type
Statement

Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, 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
K213141
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/28/2022
Days to Decision
243 days
Submission Type
Statement