Last synced on 14 November 2025 at 11:06 pm

ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

Page Type
Cleared 510(K)
510(k) Number
K013537
510(k) Type
Traditional
Applicant
KOON SENG SDN.BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
12/7/2001
Days to Decision
45 days
Submission Type
Statement

ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

Page Type
Cleared 510(K)
510(k) Number
K013537
510(k) Type
Traditional
Applicant
KOON SENG SDN.BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
12/7/2001
Days to Decision
45 days
Submission Type
Statement