Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color— 510(k) K210388
Substantially EquivalentMexpo International, Inc.
FDA 510(k) clearance K210388 for Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color, Substantially Equivalent on 2021-12-13. Applicant: Mexpo International, Inc.. Device class: 1.
Clearance details
- Applicant
- Mexpo International, Inc.
- 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
- Union City, CA, US
Recent devices under product code LZA
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- K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more
- K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more
More clearances from Mexpo International, Inc.
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.