Recall Z-2828-2018— Cypress Medical Products LLC

Name: FDA recall Z-2828-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-02

Class II · Terminated

Class II FDA medical device recall by Cypress Medical Products LLC, initiated 2018-07-02, terminated 2023-04-07. It names one FDA 510(k) clearance: K093276. Product: Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.. Reason: 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 certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material..

Recalling firm: Cypress Medical Products LLC
Classification: Class II
Status: Terminated
Initiated: 2018-07-02
Terminated: 2023-04-07
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K093276 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESTangshan Kangyuan Glove Co., Ltd.·cleared 2009-11-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.

Reason for recall

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 certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.

Data sourced from openFDA. This site is unofficial and independent of the FDA.