POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE— 510(k) K001190
Substantially EquivalentKossan Latex Industries(M)Sdn Bhd
FDA 510(k) clearance K001190 for POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE, Substantially Equivalent on 2000-05-23. Applicant: Kossan Latex Industries(M)Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Kossan Latex Industries(M)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
- Traditional
- Location
- Klang, Selangor, MY
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