Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim— 510(k) K160467
Substantially EquivalentKossan International Sdn Bhd
FDA 510(k) clearance K160467 for Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim, Substantially Equivalent on 2016-08-02. Applicant: Kossan International Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Kossan International Sdn Bhd
- Product code
- Code LZA
- 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, MY
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More clearances from Kossan International Sdn Bhd
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- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K191800 — Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
- K190606 — Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.