Hpi Sensi Grip Sterile Powdered Latex Surgical Glove, with Labeled Protein Content and Made From Allotex an Enzyme Treat

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

510(k) Number

K013324 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Accutouch Powder Free Natural Rubber Latex Patient Examination Glove

  Class I

  FDA 510(k) K992428 Active Cleared 9 Aug 1999

• Ultra Care 2 Latex Examination Gloves Made From Allotex (Enzyme Treated) Natural Rubber Latex with a Protein Content Lab

  Class I

  FDA 510(k) K002718 Active Cleared 1 May 2001

• Sensigrip Ltc Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K004048 Active Cleared 6 Feb 2001

• Formula One Powdered Latex Examination Glove, with Protein Content Labeling Claim 200 Micrograms or Less and Made From a

  Class I

  FDA 510(k) K002719 Active Cleared 26 Jan 2001

• Powder Free Plus Patient Examination Glove

  Class I

  FDA 510(k) K954855 Active Cleared 28 Dec 1995

• Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove

  Class I

  FDA 510(k) K982505 Active Cleared 2 Apr 1999

See all devices from Tillotson Healthcare Corp. →