MULTIPLE NAME— 510(k) K123819
Substantially EquivalentTop Calibre Sdn Bhd
FDA 510(k) clearance K123819 for MULTIPLE NAME, Substantially Equivalent on 2013-03-05. Applicant: Top Calibre Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Top Calibre 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
- Shah Alam, MY
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- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Top Calibre Sdn Bhd
view all- K133949 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K120692 — LATEX EXAMINATION GLOVES (POWDER FREE)
- K120693 — LATEX EXAMINATION GLOVES (POWDERED)
- K112612 — POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
Data sourced from openFDA. This site is unofficial and independent of the FDA.