Vinyl examination gloves
FDA 510(k) clearance K230046 · decided 2023-03-25
Clearance details
- K-number
- K230046
- Device name
- Vinyl examination gloves
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-06
- Decision date
- 2023-03-25
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LYZ
- 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.