Playboy Premium Silicone Lubricant
Summary
Thai Nippon Rubber Industry Public Company Limited. received 510(k) clearance for Playboy Premium Silicone Lubricant, a NUC device. Cleared on 2021-11-23.
Details
Source
510(k) Clearance
External ID
K210095
Action Date
2021-11-23
Status
Traditional
Category
device
Product Code
NUC
Product Description
Playboy Premium Silicone Lubricant. Product code: NUC.
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. Thai Nippon Rubber Industry Public Company Limited. has received 4 total clearances in our database.
Thai Nippon Rubber Industry Public Company Limited. 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 Thai Nippon Rubber Industry Public Company Limited. have FDA actions?
Thai Nippon Rubber Industry Public Company Limited. 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 "K210095" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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