Cleared Traditional

PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)

K905765 · Tillotson Rubber Co., Inc. · General Hospital

Feb 1991

Decision

60d

Days

Class 1

Risk

About This 510(k) Submission

K905765 is an FDA 510(k) clearance for the PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES), a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Tillotson Rubber Co., Inc. (Newton Centre, US). The FDA issued a Cleared decision on February 25, 1991, 60 days after receiving the submission on December 27, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K905765 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1990
Decision Date	February 25, 1991
Days to Decision	60 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

Device Classification

Product Code	LYY — Latex Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.