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510(k) K021059

SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM by Syntex Healthcare Products Co., Ltd. — Product Code LYY

K021059 is an FDA 510(k) premarket notification submitted by Syntex Healthcare Products Co., Ltd. for the device "SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM". The FDA issued a decision of Substantially Equivalent on May 14, 2002. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Syntex Healthcare Products Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2002
Date Received
April 2, 2002
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 Syntex Healthcare Products Co., Ltd.

  • K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Dr (April 2, 2024)
  • K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemoth (September 8, 2023)
  • K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (April 21, 2011)
  • K102096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (October 4, 2010)
  • K052877 — POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE (November 8, 2005)
  • K042226 — SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY (September 30, 2004)
  • K033777 — ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (February 5, 2004)
  • K023826 — SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR (January 24, 2003)
  • K022784 — SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR (November 13, 2002)
  • K022146 — SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE (September 3, 2002)

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