Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein— 510(k) K170779
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K170779 for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein, Substantially Equivalent on 2017-05-24. Applicant: Terang Nusa Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Terang Nusa Sdn Bhd
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kota Bharu, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.