Home / 510(k) Clearances / K013537

510(k) K013537

ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) by Koon Seng Sdn Bhd — Product Code LYY

K013537 is an FDA 510(k) premarket notification submitted by Koon Seng Sdn Bhd for the device "ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)". The FDA issued a decision of Substantially Equivalent on Dec 7, 2001. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Koon Seng Sdn Bhd has 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 7, 2001
Date Received
Oct 23, 2001
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 Koon Seng Sdn Bhd

  • K212613 — Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with… (Dec 21, 2021)
  • K171171 — KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use… (Feb 22, 2018)
  • K110960 — ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE (Jul 14, 2011)
  • K093375 — KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT… (Dec 2, 2009)
  • K012714 — ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN… (Oct 31, 2001)
  • K891821 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)

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