PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove— 510(k) K231973
Substantially EquivalentIneo Tech Sdn Bhd
FDA 510(k) clearance K231973 for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Substantially Equivalent on 2023-09-29. Applicant: Ineo Tech Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Ineo Tech 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
- Bandar Kassia, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.