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A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153744
510(k) Type
Traditional
Applicant
A1 GLOVE SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/4/2016
Days to Decision
220 days
Submission Type
Summary

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153744
510(k) Type
Traditional
Applicant
A1 GLOVE SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
8/4/2016
Days to Decision
220 days
Submission Type
Summary