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

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

510(k) Number

K210656 ↗

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

  Class I

  FDA 510(k) K202765 Active Cleared 27 May 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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