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Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein

K202449 Class I Traditional
Decision Date
2020-11-18
Sponsor / Applicant
Medline Industries, Inc.

Technical Specification

510(k) Submission ID K202449
Product Code KGO
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4460
Decision Date 2020-11-18
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein received FDA 510(k) clearance under submission number K202449, sponsored by Medline Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-11-18.

Classification & Regulation

This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.