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510(k) K102790

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG by Perusahaan Getah Asas Sdn. Bhd. — Product Code LZC

K102790 is an FDA 510(k) premarket notification submitted by Perusahaan Getah Asas Sdn. Bhd. for the device "POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG". The FDA issued a decision of Substantially Equivalent on Nov 29, 2010. The device falls under product code LZC (Medical Glove, Specialty), 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
Nov 29, 2010
Date Received
Sep 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type
510(k)

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

Other clearances by Perusahaan Getah Asas Sdn. Bhd.

  • 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)
  • K030335 — ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED (Mar 3, 2003)

Other clearances for product code LZC

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (Jan 14, 2026)
  • K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use… (Feb 24, 2025)
  • K221157 — JR Medic (Aug 30, 2022)
  • K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs… (Aug 27, 2022)
  • K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy… (May 26, 2022)
  • K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy… (May 14, 2022)
  • K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy… (Mar 31, 2022)
  • K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy… (Mar 10, 2022)
  • K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy… (Jan 28, 2022)
  • K213076 — AspenMed+ (Dec 20, 2021)

FDA data resources

Source: FDA 510(k) database entry for K102790. Report a data issue: hello@regdatalab.com.