Atlas FDA

Powder-Free Latex examination gloves

FDA 510(k) clearance K222612 · decided 2022-11-25

Clearance details

K-number
K222612
Device name
Powder-Free Latex examination gloves
Applicant
Guangdong Kingfa Sci. & Tech.Co., Ltd.
Decision
Substantially Equivalent
Date received
2022-08-30
Decision date
2022-11-25
Days to decision
87 days
Clearance type
Traditional
Product code
LYY
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.