SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE— 510(k) K130450
Substantially EquivalentPurna Bina Sdn Bhd
FDA 510(k) clearance K130450 for SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE, Substantially Equivalent on 2014-09-30. Applicant: Purna Bina Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Purna Bina Sdn 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
- Kluang, Johor, MY
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More clearances from Purna Bina Sdn Bhd
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Data sourced from openFDA. This site is unofficial and independent of the FDA.