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Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202078
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/5/2021
Days to Decision
221 days
Submission Type
Statement

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202078
510(k) Type
Traditional
Applicant
Shen Wei USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/5/2021
Days to Decision
221 days
Submission Type
Statement