ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K202765 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)

  Class I

  FDA 510(k) K203705 Active Cleared 20 Aug 2021

• ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs

  Class I

  FDA 510(k) K210656 Active Cleared 24 Jun 2021

• POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).

  Class I

  FDA 510(k) K142862 Active Cleared 16 Jan 2015

• Latex Examination Glove Powder Free

  Class I

  FDA 510(k) K152593 Active Cleared 25 Feb 2016

• Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

  Class I

  FDA 510(k) K211621 Active Cleared 6 Oct 2021

• POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)

  Class I

  FDA 510(k) K142858 Active Cleared 9 Feb 2015

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