NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735— 510(k) K030207
Substantially EquivalentShanghai Motex Healthcare Co., Ltd.
FDA 510(k) clearance K030207 for NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735, Substantially Equivalent on 2003-05-02. Applicant: Shanghai Motex Healthcare Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Shanghai Motex Healthcare 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
- Qingpu, Shanghai, CN
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More clearances from Shanghai Motex Healthcare Co., Ltd.
view all- K123126 — MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
- K132802 — MOTEX POWDERED NITRILE SURGICAL GLOVES
- K122557 — MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
- K063757 — MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
- K041276 — POWDER-FREE NITRILE EXAMINATION GLOVES
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.