Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid— 510(k) K221773
Substantially EquivalentOnetexx Sdn Bhd
FDA 510(k) clearance K221773 for Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid, Substantially Equivalent on 2022-07-30. Applicant: Onetexx Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Onetexx 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
- Kamunting, MY
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More clearances from Onetexx Sdn Bhd
view all- K222298 — Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
- K222294 — Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
- K210588 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K210587 — Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
- K210775 — White Nitrile Powder Free Patient Examination Glove, 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.