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 Wembley Rubber Products (M) Sdn Bhd, Sgmp Co., Ltd. and Hartalega Sdn Bhd.

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 Jun 23, 2017
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
K170094
Vietglove Corporation
General Hospital · 163d
Cleared May 24, 2017
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
K170779
Terang Nusa Sdn Bhd
General Hospital · 70d
Cleared May 23, 2017
LATEX EXAMINATION GLOVE POWDER FREE
K161833
Careglove Global Sdn. Bhd.
General Hospital · 322d
Cleared May 11, 2017
UniTex Non-Sterile, Powder-Free, Latex Examination Glove
K161961
Ug Global Resources Sdn. Bhd.
General Hospital · 297d
Cleared Nov 21, 2016
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
K162175
Vietglove Corporation
General Hospital · 110d
Cleared Aug 04, 2016
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
K153744
A1 Glove Sdn Bhd
General Hospital · 220d
Cleared Aug 04, 2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006
Hartalega Sdn Bhd
General Hospital · 115d
Cleared Feb 25, 2016
LATEX EXAMINATION GLOVE POWDER FREE
K152593
Careplus (M) Sdn Bhd
General Hospital · 168d
Cleared Nov 16, 2015
Annuy Latex Patient Examination Glove (powdered and powder-free)
K150612
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Mar 19, 2015
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
K141042
Mercator Medical (Thailand), Ltd.
General Hospital · 330d
Cleared Mar 06, 2015
Patient Examination Gloves
K143419
Hartalega NGC Sdn. Bhd.
General Hospital · 98d
Cleared Nov 25, 2014
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
K142270
Hartalega Sdb. Bhd.
General Hospital · 102d
Cleared May 28, 2014
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953
Hartalega Sdn Bhd
General Hospital · 156d
Cleared Feb 12, 2014
POWDER FREE LATEX EXAMINATION GLOVES
K123537
Qube Medical Product Sdn Bhd
General Hospital · 453d
Cleared Sep 06, 2013
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K121844
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 438d
Cleared Jul 24, 2013
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
K130667
Preventive Care, Inc.
General Hospital · 134d
Cleared May 07, 2013
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368
Hartalega Sdn Bhd
General Hospital · 187d
Cleared Mar 05, 2013
MULTIPLE NAME
K123819
Top Calibre Sdn Bhd
General Hospital · 83d