EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE— 510(k) K141590
Substantially EquivalentEco Medi Glove Sdn. Bhd.
FDA 510(k) clearance K141590 for EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE, Substantially Equivalent on 2014-09-03. Applicant: Eco Medi Glove Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Eco Medi Glove Sdn. Bhd.
- 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
- Kamunting Perak, MY
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More clearances from Eco Medi Glove Sdn. Bhd.
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- K202401 — Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
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.