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510(k) K003737

POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) by Perusahaan Getah Asas Sdn. Bhd. — Product Code LYY

K003737 is an FDA 510(k) premarket notification submitted by Perusahaan Getah Asas Sdn. Bhd. for the device "POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)". The FDA issued a decision of Substantially Equivalent on Feb 1, 2001. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Perusahaan Getah Asas Sdn. Bhd. has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 1, 2001
Date Received
Dec 4, 2000
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 Perusahaan Getah Asas Sdn. Bhd.

  • K102790 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW… (Nov 29, 2010)
  • K042805 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE (Dec 16, 2004)
  • K032374 — POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED (Oct 22, 2003)
  • K031768 — BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED)… (Aug 1, 2003)
  • K031625 — POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND… (Aug 1, 2003)
  • K031591 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND… (Jun 26, 2003)
  • K031414 — POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE… (Jun 26, 2003)
  • K031021 — CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (Jun 13, 2003)
  • K030333 — LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING… (Mar 21, 2003)
  • K030331 — ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN… (Mar 21, 2003)

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

Source: FDA 510(k) database entry for K003737. Report a data issue: hello@regdatalab.com.