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510(k) K101828

POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS by Gx Corporation Sdn Bhd — Product Code LYY

K101828 is an FDA 510(k) premarket notification submitted by Gx Corporation Sdn Bhd for the device "POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS". The FDA issued a decision of Substantially Equivalent on Oct 4, 2010. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Gx Corporation Sdn Bhd has 17 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 4, 2010
Date Received
Jul 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type
510(k)

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.

Other clearances by Gx Corporation Sdn Bhd

  • K200915 — Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with… (Jul 9, 2021)
  • K183354 — Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy… (Jun 20, 2019)
  • K111328 — POWDER FREE NITRILE EXAMINATION GLOVES (Jul 15, 2011)
  • K102074 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS… (Nov 2, 2010)
  • K091851 — STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH… (Dec 28, 2009)
  • K092072 — POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE (Nov 4, 2009)
  • K091643 — POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY… (Nov 2, 2009)
  • K092200 — POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA… (Sep 16, 2009)
  • K090412 — POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). (Jun 1, 2009)
  • K091151 — POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN (Jun 1, 2009)

Other clearances for product code LYY

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and… (Apr 29, 2025)
  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (Sep 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with… (Jun 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (Feb 22, 2023)
  • K222612 — Powder-Free Latex examination gloves (Nov 25, 2022)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (Oct 28, 2022)
  • K222348 — JR MEDIC (Oct 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (Oct 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (Sep 24, 2022)
  • K221648 — Iconic Latex Glove (Aug 25, 2022)

FDA data resources