NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE— 510(k) K051094
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K051094 for NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE, Substantially Equivalent on 2005-06-06. Applicant: Terang Nusa Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Terang Nusa 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
- Special
- Location
- Kota Bharu, Kelantan, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.