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Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243133
510(k) Type
Traditional
Applicant
Kl-Kepong Rubber Products Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
6/17/2025
Days to Decision
260 days
Submission Type
Summary

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243133
510(k) Type
Traditional
Applicant
Kl-Kepong Rubber Products Sdn. Bhd.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
6/17/2025
Days to Decision
260 days
Submission Type
Summary