Sterile Surgical Powder Free Latex Glove
Summary
New Era Medicare Sdn. Bhd. received 510(k) clearance for Sterile Surgical Powder Free Latex Glove, a KGO device. Cleared on 2023-01-26.
Details
Source
510(k) Clearance
External ID
K221424
Action Date
2023-01-26
Status
Traditional
Category
device
Product Code
KGO
Product Description
Sterile Surgical Powder Free Latex Glove. Product code: KGO.
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. New Era Medicare Sdn. Bhd. has received 3 total clearances in our database.
New Era Medicare Sdn. Bhd. has 3 FDA actions in our database, including 3 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 New Era Medicare Sdn. Bhd. have FDA actions?
New Era Medicare Sdn. Bhd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221424" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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