Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)— 510(k) K160928
Substantially EquivalentHartalega Sdb. Bhd.
FDA 510(k) clearance K160928 for Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green), Substantially Equivalent on 2016-12-20. Applicant: Hartalega Sdb. Bhd.. Device class: 1.
Clearance details
- Applicant
- Hartalega Sdb. Bhd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bandar Sri Damansara, MY
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More clearances from Hartalega Sdb. Bhd.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.