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510(k) K083305

POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM by Wrp Asia Pacific Sdn. Bhd. — Product Code LZC

K083305 is an FDA 510(k) premarket notification submitted by Wrp Asia Pacific Sdn. Bhd. for the device "POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM". The FDA issued a decision of Substantially Equivalent on June 18, 2009. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Wrp Asia Pacific Sdn. Bhd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2009
Date Received
November 10, 2008
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 Wrp Asia Pacific Sdn. Bhd.

  • K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C (March 28, 2024)
  • K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE (November 17, 2023)
  • K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with (August 31, 2023)
  • K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemother (October 22, 2022)
  • K211601 — Powder Free Latex Examination Glove, Non-Sterile (August 22, 2022)
  • K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with C (March 4, 2022)
  • K203030 — POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DR (June 11, 2021)
  • K192635 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (January 17, 2020)
  • K161823 — Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Dr (January 23, 2017)
  • K161422 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TEST (October 20, 2016)

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)
  • K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy D (May 26, 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)

FDA data resources