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510(k) K211220

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs by Guangdong Kingfa Sci. & Tech.Co., Ltd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2021
Date Received
April 23, 2021
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 Guangdong Kingfa Sci. & Tech.Co., Ltd.

  • K233723 — Medical surgical mask (July 29, 2024)
  • K231155 — Biodegradable Medical surgical mask (November 7, 2023)
  • K221983 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable P (April 27, 2023)
  • K230046 — Vinyl examination gloves (March 25, 2023)
  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
  • K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (October 7, 2022)
  • K221887 — Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, N (September 24, 2022)
  • K213040 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (April 27, 2022)
  • K213450 — Medical surgical mask (Black mask, Level 1 and Level 3) (April 5, 2022)
  • K203593 — Patient Examination Gloves (March 19, 2021)

Other clearances for product code LZA

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  • 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)
  • K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid F (August 27, 2025)
  • K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit (August 21, 2025)
  • K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, (August 18, 2025)
  • K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy D (July 30, 2025)
  • K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opi (July 9, 2025)