Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid a
Summary
Hartalega NGC Sdn. Bhd. received 510(k) clearance for Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black), a LZA device. Cleared on 2025-10-23.
Details
Source
510(k) Clearance
External ID
K250861
Action Date
2025-10-23
Status
Traditional
Category
device
Product Code
LZA
Product Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black). 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. Hartalega NGC Sdn. Bhd. has received 9 total clearances in our database.
Hartalega NGC Sdn. Bhd. has 9 FDA actions in our database, including 9 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 Hartalega NGC Sdn. Bhd. have FDA actions?
Hartalega NGC Sdn. Bhd. has 9 FDA actions in our database, including 0 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250861" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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