Class Class I
Disposable Nitrile Examination Glove (K223250)
Description
Disposable Nitrile Examination Glove by Yangzhou Saraguard Medical Supplies Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK223250
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223250
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. Disposable Nitrile Examination Glove (K223250) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203593 | Patient Examination Gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 |
| K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Bl... | Ever Global (Vietnam) Enterprise Corp | 2018 |
Trace the full predicate network for K223250
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.