Black Nitrile Powder Free Patient Examination Glove, Non Sterile— 510(k) K212916
Substantially EquivalentRimba Glove Sdn Bhd
FDA 510(k) clearance K212916 for Black Nitrile Powder Free Patient Examination Glove, Non Sterile, Substantially Equivalent on 2022-03-24. Applicant: Rimba Glove Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Rimba Glove Sdn Bhd
- Product code
- Product 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
- Ipoh, MY
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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.