Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove— 510(k) K161006
Substantially EquivalentHartalega Sdn Bhd
FDA 510(k) clearance K161006 for Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove, Substantially Equivalent on 2016-08-04. Applicant: Hartalega Sdn Bhd.
Clearance details
- Applicant
- Hartalega Sdn Bhd
- Product code
- Code LYY
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bandar Sri Damansara, MY
Data sourced from openFDA. This site is unofficial and independent of the FDA.