Home › Hans Hepp GmbH & Co. KG › Disposable Gloves Size L

Disposable Gloves Size L

Hans Hepp GmbH & Co. KG · Model 92401 · UDI-DI 04007418924016

LYZ

510(k) clearances

211

Adverse events

Recalls

132

Facilities

Description

A non-sterile device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Recalls

Date	Firm	Reason
2018-07-02	Cypress Medical Products LLC	The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that c
2016-10-12	CYPRESS MEDICAL PRODUCTS	A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
2012-06-20	Gulf South Medical Supply Inc	Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
2011-11-15	Cypress Medical Products LLC	The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2011-11-15	Cypress Medical Products LLC	The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2011-11-15	Cypress Medical Products LLC	The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2009-04-30	Kimberly-Clark Corporation	The product may contain defects/holes reducing the product's effectiveness as a barrier.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.