LYY · Class I · 21 CFR 880.6250

FDA Product Code LYY: Latex Patient Examination Glove

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.

Leading manufacturers include Medline Industries, Inc., Baxter Healthcare Corp and Sri Trang Gloves (Thailand) Public Company Limited.

1954
Total
1954
Cleared
104d
Avg days
1988
Since
1954 devices
25–48 of 1954
Cleared Aug 19, 2021
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
K211620
Shen Wei (Usa), Inc.
General Hospital · 85d
Cleared May 19, 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576
Pt. Universal Gloves
General Hospital · 342d
Cleared Dec 01, 2020
Palm Care Latex Examination Powder Free Gloves
K202377
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 103d
Cleared Nov 25, 2019
Blue Latex Examination Powder Free Gloves
K192329
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 90d
Cleared Jun 06, 2018
POWDER FREE LATEX EXAMINATION GLOVE
K173053
Professional Latex Sdn Bhd
General Hospital · 251d
Cleared Jan 26, 2018
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
K171367
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 262d
Cleared Apr 21, 2011
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602
Medline Industries, Inc.
General Hospital · 134d
Cleared Jan 26, 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055
Medline Industries, Inc.
General Hospital · 116d
Cleared Nov 19, 1996
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096
Medline Industries, Inc.
General Hospital · 175d
Cleared Aug 23, 1996
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6)
K962076
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962094
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES
K962095
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K894022
Baxter Healthcare Corp
General Hospital · 86d
Cleared Aug 09, 1989
B-D PATIENT EXAMINATION GLOVES
K894280
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 47d
Cleared Jul 14, 1989
ACCU-TOUCH LATEX EXAM GLOVES, UNISIZE & LARGE
K891791
Medline Industries, Inc.
General Hospital · 113d
Cleared Jul 14, 1989
MEDLINE LATEX EXAM GLOVES
K892075
Medline Industries, Inc.
General Hospital · 102d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892750
Baxter Healthcare Corp
General Hospital · 94d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES (DENTAL)
K892751
Baxter Healthcare Corp
General Hospital · 94d