Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
FDA 510(k) clearance K222714 · decided 2022-10-07
Clearance details
- K-number
- K222714
- Device name
- Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-08
- Decision date
- 2022-10-07
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Qingyuan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.