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POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)

K003737 Class I Traditional
Decision Date
2001-02-01
Sponsor / Applicant
Perusahaan Getah Asas Sdn. Bhd.

Technical Specification

510(k) Submission ID K003737
Product Code LYY
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6250
Decision Date 2001-02-01
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) received FDA 510(k) clearance under submission number K003737, sponsored by Perusahaan Getah Asas Sdn. Bhd.. 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 2001-02-01.

Classification & Regulation

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