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Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein

K172942 Class I Abbreviated
Decision Date
2018-01-08
Sponsor / Applicant
Beta Healthcare Products Pvt., Ltd.

Technical Specification

510(k) Submission ID K172942
Product Code KGO
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4460
Decision Date 2018-01-08
Clearance Pathway Abbreviated

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein received FDA 510(k) clearance under submission number K172942, sponsored by Beta Healthcare Products Pvt., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-01-08.

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.