Last synced on 14 November 2025 at 11:06 pm

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS

Page Type
Cleared 510(K)
510(k) Number
K993760
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/15/2000
Days to Decision
189 days
Submission Type
Statement

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS

Page Type
Cleared 510(K)
510(k) Number
K993760
510(k) Type
Traditional
Applicant
HARTALEGA SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
5/15/2000
Days to Decision
189 days
Submission Type
Statement