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510(k) K100211

PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA by Shen Wei (Usa), Inc. — Product Code LYY

K100211 is an FDA 510(k) premarket notification submitted by Shen Wei (Usa), Inc. for the device "PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA". The FDA issued a decision of Substantially Equivalent on May 11, 2010. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Shen Wei (Usa), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2010
Date Received
January 25, 2010
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 Shen Wei (Usa), Inc.

  • K161074 — Powder Free Nitrile Examination Gloves Flock-Lined, Black Color (November 17, 2016)
  • K121811 — POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES (November 21, 2012)
  • K121528 — POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (September 11, 2012)
  • K120890 — POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE (August 17, 2012)
  • K113233 — POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CL (March 29, 2012)
  • K101436 — PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, G (November 17, 2010)
  • K092411 — PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, (October 21, 2009)
  • K090194 — POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR (July 7, 2009)
  • K061756 — TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP (April 19, 2007)
  • K062919 — TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) (March 20, 2007)

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)
  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
  • 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)

FDA data resources