STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G— 510(k) K013727
Substantially EquivalentSmart Glove Corp. Sdn Bhd
FDA 510(k) clearance K013727 for STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G, Substantially Equivalent on 2001-12-07. Applicant: Smart Glove Corp. Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Smart Glove Corp. 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
- Klang Selangor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.