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

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

510(k) Number

K013537 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Royal Imperial Nitrile Examination Gloves Textured Powder-Free

  Class I

  FDA 510(k) K110960 Active Cleared 14 Jul 2011

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

  Class I

  FDA 510(k) K012714 Active Cleared 31 Oct 2001

• Patient Examination Gloves (Latex)

  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

• KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)

  Class I

  FDA 510(k) K171171 Active Cleared 22 Feb 2018