Recall Z-2036-2018— WRP Asia Pacific Sdn Bhd

Name: FDA recall Z-2036-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-07

Class II · Terminated

Class II FDA medical device recall by WRP Asia Pacific Sdn Bhd, initiated 2018-05-07, terminated 2019-05-30. It names one FDA 510(k) clearance: K020019. Product: AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112. Reason: Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue..

Recalling firm: WRP Asia Pacific Sdn Bhd
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Terminated: 2019-05-30
Firm location: Sepang, N/A, Malaysia

510(k) clearances named in this recall

1 on FDA's record

K020019 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)Wrp Asia Pacific Sdn. Bhd.·cleared 2002-01-23

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

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

Reason for recall

Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.

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