Class Class I
APOLLO ADVANTAGE Nitrile Examination Gloves (K230633)
Description
APOLLO ADVANTAGE Nitrile Examination Gloves by Dell Corning Corporation, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK230633
Clearance Date2023-06-05
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230633
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. APOLLO ADVANTAGE Nitrile Examination Gloves (K230633) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213739 | Nitrile Examination Gloves | Hangzhou Runheng Medical Co., Ltd. | 2022 |
Trace the full predicate network for K230633
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.