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510(k) K010863

LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) by La Glove (M) Sdn. Bhd. — Product Code LZA

K010863 is an FDA 510(k) premarket notification submitted by La Glove (M) Sdn. Bhd. for the device "LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)". The FDA issued a decision of Substantially Equivalent on May 3, 2001. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. La Glove (M) Sdn. Bhd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
March 22, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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)
  • K092499 — LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN (November 20, 2009)
  • K092498 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) (November 20, 2009)
  • K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BL (November 26, 2004)
  • 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)
  • K990883 — LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) (August 10, 1999)

Other clearances for product code LZA

  • K252117 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use (June 24, 2026)
  • K253824 — Powder Free Nitrile Examination Gloves Non-Sterile Black (June 18, 2026)
  • K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs an (June 17, 2026)
  • K260806 — Nitrile Disposable Examination Gloves (June 3, 2026)
  • K260703 — Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Dr (June 3, 2026)
  • K253160 — Syntex Exam Gloves (January 23, 2026)
  • K252549 — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tes (January 13, 2026)
  • K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested (November 17, 2025)
  • K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe (October 23, 2025)
  • K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves (October 17, 2025)

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