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Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202082
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/2021
Days to Decision
233 days
Submission Type
Statement

Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202082
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/2021
Days to Decision
233 days
Submission Type
Statement