Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (K223298)
Description
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) by Shandong Intco Medical Products Co, Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
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Predicate lineage for K223298
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. Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (K223298) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171367 | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as ... | Sanrea Healthcare Products Pvt, Ltd. | 2018 |
Trace the full predicate network for K223298
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.