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510(k) K081488

POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE by Pt. Maja Agung Latexindo — Product Code LYY

K081488 is an FDA 510(k) premarket notification submitted by Pt. Maja Agung Latexindo for the device "POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE". The FDA issued a decision of Substantially Equivalent on Aug 28, 2008. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Pt. Maja Agung Latexindo has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 28, 2008
Date Received
May 28, 2008
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
510(k)

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 Pt. Maja Agung Latexindo

  • K212408 — Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs… (May 18, 2022)
  • K161099 — Powder Free Nitrile Examination Gloves, Black (Feb 23, 2017)
  • K062709 — POWDER FREE LATEX EXAMINATION GLOVES, BLACK (Dec 6, 2006)
  • K020040 — LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM (Aug 1, 2002)
  • K013996 — LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM… (Feb 26, 2002)
  • K001274 — LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM… (Jun 23, 2000)
  • K994255 — LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE (Feb 7, 2000)
  • K992752 — SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 (Nov 5, 1999)
  • K982897 — POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50… (Dec 23, 1998)
  • K896604 — MAL LATEX EXAMINATION GLOVES (Jan 2, 1990)

Other clearances for product code LYY

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and… (Apr 29, 2025)
  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (Sep 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with… (Jun 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (Feb 22, 2023)
  • K222612 — Powder-Free Latex examination gloves (Nov 25, 2022)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (Oct 28, 2022)
  • K222348 — JR MEDIC (Oct 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (Oct 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (Sep 24, 2022)
  • K221648 — Iconic Latex Glove (Aug 25, 2022)

FDA data resources