Zoupure Nitrile Powder Free Examination glove— 510(k) K220693
Substantially EquivalentThai Rayong Product Glove Zoupure Co., Ltd.
FDA 510(k) clearance K220693 for Zoupure Nitrile Powder Free Examination glove, Substantially Equivalent on 2022-06-07. Applicant: Thai Rayong Product Glove Zoupure Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Thai Rayong Product Glove Zoupure Co., Ltd.
- 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
- Bankhai, TH
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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.