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510(k) K982872

TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) by Tg Medical Sdn. Bhd. — Product Code LYY

K982872 is an FDA 510(k) premarket notification submitted by Tg Medical Sdn. Bhd. for the device "TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)". The FDA issued a decision of Substantially Equivalent on Oct 15, 1998. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Tg Medical Sdn. Bhd. has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 15, 1998
Date Received
Aug 14, 1998
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 Tg Medical Sdn. Bhd.

  • K171276 — Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy… (Aug 21, 2017)
  • K113393 — POWDER FREE BLACK NITRILE EXAMINATION GLOVES (Sep 11, 2012)
  • K993562 — POWDER FREE LATEX STERILE SURGICAL GLOVES (Dec 29, 1999)
  • K992841 — TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES (Oct 29, 1999)
  • K992360 — TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES (Oct 12, 1999)
  • K992219 — POWDERED LATEX STERILE SURGICAL GLOVES (Jul 30, 1999)
  • K990668 — POWDER FREE BLUE NITRILE GLOVE (Jun 3, 1999)
  • K941900 — POWDERED LATEX EXAM GLOVES (Jun 21, 1994)

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