K232461
- 510(k) number
- K232461
- Device name
- Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis
- Applicant
- Kossan International Sdn Bhd MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-11-14
- Date received
- 2023-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232461
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.