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510(k) K953213

COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) by Wembley Rubber Products (M) Sdn Bhd — Product Code LYY

K953213 is an FDA 510(k) premarket notification submitted by Wembley Rubber Products (M) Sdn Bhd for the device "COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)". The FDA issued a decision of Substantially Equivalent on October 11, 1996. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Wembley Rubber Products (M) Sdn Bhd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1996
Date Received
July 10, 1995
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 Wembley Rubber Products (M) Sdn Bhd

  • K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) (March 12, 1999)
  • K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (January 27, 1999)
  • K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (January 26, 1999)
  • K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) (October 24, 1997)
  • K962189 — COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (July 26, 1996)
  • K962188 — COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (July 26, 1996)
  • K953590 — COMFIT (June 27, 1996)
  • K960178 — COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) (May 6, 1996)
  • K960407 — COMFIT ORTHOPEDIC (April 26, 1996)
  • K960416 — COMFIT MICROPTIC (April 26, 1996)

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)

FDA data resources