Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet
Summary
Top Glove Sdn. Bhd. received 510(k) clearance for Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim, a LZA device. Cleared on 2026-09-09.
Details
Source
510(k) Clearance
External ID
K262542
Action Date
2026-09-09
Status
Special
Category
device
Product Code
LZA
Product Description
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim. 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 445 device clearances issued this month.
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 Top Glove Sdn. Bhd. have FDA actions?
This is the only FDA action we have on record for Top Glove Sdn. Bhd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K262542" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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