STERILE EXTRA PROTECION SURGEON'S GLOVES— 510(k) K922979
Substantially EquivalentAnsell Malaysia Sdn Bhd
FDA 510(k) clearance K922979 for STERILE EXTRA PROTECION SURGEON'S GLOVES, Substantially Equivalent on 1995-01-18. Applicant: Ansell Malaysia Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Ansell Malaysia 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
- Melaka, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.