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510(k) K100369

POWDER-FREE NITRILE GLOVES, BLACK by Hl Rubber Industries Sdn Bhd — Product Code LZA

K100369 is an FDA 510(k) premarket notification submitted by Hl Rubber Industries Sdn Bhd for the device "POWDER-FREE NITRILE GLOVES, BLACK". The FDA issued a decision of Substantially Equivalent on May 20, 2010. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Hl Rubber Industries Sdn Bhd has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2010
Date Received
February 12, 2010
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 Hl Rubber Industries Sdn Bhd

  • K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy D (May 26, 2022)
  • K141021 — POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR (August 26, 2014)
  • K140316 — EXAMINATION GLOVES (July 11, 2014)
  • K130038 — POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE (February 21, 2013)
  • K063522 — POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) (February 8, 2007)
  • K063524 — POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) (January 23, 2007)

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)

FDA data resources