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510(k) K220545

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs by Hl Rubber Industries Sdn Bhd — Product Code LZC

K220545 is an FDA 510(k) premarket notification submitted by Hl Rubber Industries Sdn Bhd for the device "Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on May 26, 2022. The device falls under product code LZC (Medical Glove, Specialty), 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 26, 2022
Date Received
February 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

Other clearances by Hl Rubber Industries Sdn Bhd

  • 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)
  • K100369 — POWDER-FREE NITRILE GLOVES, BLACK (May 20, 2010)
  • 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 LZC

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use wi (February 24, 2025)
  • K221157 — JR Medic (August 30, 2022)
  • K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs A (August 27, 2022)
  • K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy (May 14, 2022)
  • K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Dru (March 31, 2022)
  • K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy (March 10, 2022)
  • K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy (January 28, 2022)
  • K213076 — AspenMed+ (December 20, 2021)
  • K212639 — Disposable Medical Nitrile Examination Gloves (Non sterile) (December 8, 2021)

FDA data resources