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510(k) K221983

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color by Guangdong Kingfa Sci. & Tech.Co., Ltd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2023
Date Received
July 6, 2022
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.

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  • 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)
  • K211220 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (July 22, 2021)
  • K203593 — Patient Examination Gloves (March 19, 2021)

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  • K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid F (August 27, 2025)
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  • K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy D (July 30, 2025)
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