Disposable Sterilized Latex Surgical Gloves
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Summary
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. received 510(k) clearance for Disposable Sterilized Latex Surgical Gloves, a KGO device. Cleared on 2022-05-25.
Details
Source
510(k) Clearance
External ID
K211953
Action Date
2022-05-25
Status
Traditional
Category
device
Product Code
KGO
Product Description
Disposable Sterilized Latex Surgical Gloves. Product code: KGO.
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. Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. has received 3 total clearances in our database.
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 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 Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. have FDA actions?
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 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 "K211953" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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