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510(k) K990468

LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING by Top Glove Sdn. Bhd. — Product Code LYY

K990468 is an FDA 510(k) premarket notification submitted by Top Glove Sdn. Bhd. for the device "LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING". The FDA issued a decision of Substantially Equivalent on April 27, 1999. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Top Glove Sdn. Bhd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1999
Date Received
February 16, 1999
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 Top Glove Sdn. Bhd.

  • K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitril (September 9, 2026)
  • K192111 — Biodegradable Nitrile Examination Powder Free Glove, Green (September 3, 2020)
  • K193150 — Latex Examination Powder Free Glove, Aloe Vera (June 5, 2020)
  • K172923 — Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination (April 26, 2018)
  • K171279 — Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Dru (October 12, 2017)
  • K122999 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (November 30, 2012)
  • K023974 — ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES (February 13, 2003)
  • K021855 — TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 M (August 5, 2002)
  • K993664 — SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES (January 11, 2000)
  • K993452 — GREEN POWDERED LATEX EXAMINATION GLOVES (December 20, 1999)

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