BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES— 510(k) K081971
Substantially EquivalentNitritex (M) Sdn. Bhd.
FDA 510(k) clearance K081971 for BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES, Substantially Equivalent on 2008-12-23. Applicant: Nitritex (M) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Nitritex (M) Sdn. Bhd.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kuala Langat, Selangor De, MY
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