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Patient Examination Gloves

K203593 Class I Traditional
Decision Date
2021-03-19
Sponsor / Applicant
Guangdong Kingfa Sci. & Tech.Co., Ltd.

Technical Specification

510(k) Submission ID K203593
Product Code LZA
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6250
Decision Date 2021-03-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Patient Examination Gloves received FDA 510(k) clearance under submission number K203593, sponsored by Guangdong Kingfa Sci. & Tech.Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-03-19.

Classification & Regulation

This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.