HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs— 510(k) K162381
Substantially EquivalentHealthy Glove Co., Ltd.
FDA 510(k) clearance K162381 for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2017-01-31. Applicant: Healthy Glove Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Healthy Glove 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
- Hat Yai, TH
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More clearances from Healthy Glove Co., Ltd.
view allAdverse 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.