Royal Imperial Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or

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

510(k) Number

K012714 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K110960 Active Cleared 14 Jul 2011

• Royal Imperial Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less)

  Class I

  CE/MDR FDA 510(k) K013537 Active Cleared 7 Dec 2001

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  Class I

  FDA 510(k) K891821 Active Cleared 31 May 1989

• Ks-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less)

  Class I

  FDA 510(k) K093375 Active Cleared 2 Dec 2009

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  Class I

  FDA 510(k) K171171 Active Cleared 22 Feb 2018