510(k) K990285

LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) by La Glove (M) Sdn. Bhd. — Product Code LYY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 18, 1999
Date Received: January 29, 1999
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

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 La Glove (M) Sdn. Bhd.

K093335 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) (June 18, 2010)
K093193 — LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ (June 8, 2010)
K092498 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) (November 20, 2009)
K092499 — LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN (November 20, 2009)
K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BL (November 26, 2004)
K010863 — LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPREN (May 3, 2001)
K010861 — LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) (April 3, 2001)
K010860 — LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) (April 3, 2001)
K991949 — LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) (August 12, 1999)
K991950 — LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) (August 12, 1999)

Other clearances for product code LYY

K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Prot (April 29, 2025)
K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (February 22, 2023)
K222612 — Powder-Free Latex examination gloves (November 25, 2022)
K221667 — Non Sterile Powder Free Latex Examination Glove (October 28, 2022)
K222348 — JR MEDIC (October 27, 2022)
K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
K222693 — Single-use medical latex examination gloves (LG100) (September 24, 2022)
K221648 — Iconic Latex Glove (August 25, 2022)