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510(k) K101799

POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE by Wear Safe (Malaysia) Sdn. Bhd. — Product Code LYY

K101799 is an FDA 510(k) premarket notification submitted by Wear Safe (Malaysia) Sdn. Bhd. for the device "POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE". The FDA issued a decision of Substantially Equivalent on Sep 3, 2010. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Wear Safe (Malaysia) Sdn. Bhd. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 3, 2010
Date Received
Jun 28, 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
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 Wear Safe (Malaysia) Sdn. Bhd.

  • K172420 — Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with… (Sep 29, 2017)
  • K093500 — POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED)… (Jan 19, 2010)
  • K092492 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN… (Oct 21, 2009)
  • K090066 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING… (May 15, 2009)
  • K090327 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN… (Apr 3, 2009)

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