Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs,
Summary
Eco Medi Glove Sdn. Bhd. received 510(k) clearance for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid, a LZA device. Cleared on 2024-02-26.
Details
Source
510(k) Clearance
External ID
K233560
Action Date
2024-02-26
Status
Traditional
Category
device
Product Code
LZA
Product Description
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. Product code: LZA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Eco Medi Glove Sdn. Bhd. has received 4 total clearances in our database.
Eco Medi Glove Sdn. Bhd. has 4 FDA actions in our database, including 4 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Eco Medi Glove Sdn. Bhd. have FDA actions?
Eco Medi Glove Sdn. Bhd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233560" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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