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510(k) K062917

STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 by Wear Safe Malaysia Sdn. Bhd. — Product Code LYY

K062917 is an FDA 510(k) premarket notification submitted by Wear Safe Malaysia Sdn. Bhd. for the device "STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50". The FDA issued a decision of Substantially Equivalent on Nov 2, 2006. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Wear Safe Malaysia Sdn. Bhd. has 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 2, 2006
Date Received
Sep 28, 2006
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 Wear Safe Malaysia Sdn. Bhd.

  • K062778 — STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED (Oct 27, 2006)
  • K992675 — PATIENT NITRILE EXAMINATION GLOVES (POWDERED) (Jan 20, 2000)
  • K992676 — PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES (Dec 16, 1999)
  • K992681 — PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE (Dec 16, 1999)
  • K992678 — PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED (Nov 17, 1999)
  • K992679 — SURGEON POWDER-FREE GLOVES, LATEX, STERILE (Oct 21, 1999)
  • K973020 — PATIENT EXAMINATION POWDER-FREE GLOVES (Jan 6, 1998)

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