Cleared Traditional

DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI

K040645 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Apr 2004
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K040645 is an FDA 510(k) clearance for the DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on April 28, 2004, 48 days after receiving the submission on March 11, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K040645 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2004
Decision Date April 28, 2004
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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.

Similar Devices — LYY Latex Patient Examination Glove

All 1953
Powder Free Natural Rubber Latex Examination Gloves ? Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
K250069 · Comfort Rubber Gloves Industries Sdn. Bhd. · Apr 2025
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · Sri Trang Gloves (Thailand) Public Company Limited · Sep 2024
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
K230573 · Kossan International Sdn Bhd · Jun 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · Shandong Intco Medical Products Co, Ltd. · Feb 2023
Powder-Free Latex examination gloves
K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · New Era Medicare Sdn. Bhd. · Oct 2022

More from Wrp Asia Pacific Sdn. Bhd.

View all
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
K232079 · KGO · Mar 2024
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
K232538 · LZA · Nov 2023
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
K230578 · KGO · Aug 2023
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
K222058 · KGO · Oct 2022
Powder Free Latex Examination Glove, Non-Sterile
K211601 · LYY · Aug 2022