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510(k) K222612

Powder-Free Latex examination gloves by Guangdong Kingfa Sci. & Tech.Co., Ltd. — Product Code LYY

K222612 is an FDA 510(k) premarket notification submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. for the device "Powder-Free Latex examination gloves". The FDA issued a decision of Substantially Equivalent on November 25, 2022. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Guangdong Kingfa Sci. & Tech.Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2022
Date Received
August 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A latex patient examination glove is a disposable device made of natural rubber latex 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)
  • 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)

Other clearances for product code LYY

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Prot (April 29, 2025)
  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (February 22, 2023)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (October 28, 2022)
  • K222348 — JR MEDIC (October 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (September 24, 2022)
  • K221648 — Iconic Latex Glove (August 25, 2022)
  • K211601 — Powder Free Latex Examination Glove, Non-Sterile (August 22, 2022)

FDA data resources