Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (K230217)
Description
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs by Grand Work Plastic Products Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230217
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 Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (K230217) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with... | Hartalega NGC Sdn. Bhd. | 2022 |
Trace the full predicate network for K230217
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.