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POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL

Page Type
Cleared 510(K)
510(k) Number
K050527
510(k) Type
Traditional
Applicant
SPI GLOVES SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/18/2005
Days to Decision
16 days
Submission Type
Summary

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL

Page Type
Cleared 510(K)
510(k) Number
K050527
510(k) Type
Traditional
Applicant
SPI GLOVES SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/18/2005
Days to Decision
16 days
Submission Type
Summary