SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE— 510(k) K053305
Substantially EquivalentPt Mahakarya Inti Buana
FDA 510(k) clearance K053305 for SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE, Substantially Equivalent on 2006-06-02. Applicant: Pt Mahakarya Inti Buana. Device class: 1.
Clearance details
- Applicant
- Pt Mahakarya Inti Buana
- 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
- Sumut, Indonesia, ID
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More clearances from Pt Mahakarya Inti Buana
view all- K111300 — SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
- K090464 — BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
- K063581 — SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
- K062313 — SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
- K061233 — SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
Data sourced from openFDA. This site is unofficial and independent of the FDA.