Last synced on 27 June 2025 at 11:06 pm

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211810
510(k) Type
Traditional
Applicant
PT. Shamrock Manufacturing Corpora
Country
Indonesia
FDA Decision
Substantially Equivalent
Decision Date
5/23/2022
Days to Decision
346 days
Submission Type
Summary

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211810
510(k) Type
Traditional
Applicant
PT. Shamrock Manufacturing Corpora
Country
Indonesia
FDA Decision
Substantially Equivalent
Decision Date
5/23/2022
Days to Decision
346 days
Submission Type
Summary