MAXTER STERILE POWDER FREE SURGICAL GLOVES— 510(k) K032501
Substantially EquivalentMaxter Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K032501 for MAXTER STERILE POWDER FREE SURGICAL GLOVES, Substantially Equivalent on 2003-10-17. Applicant: Maxter Glove Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Maxter Glove Manufacturing 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
- Meru, Klang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.